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Medical Device & Diagnostic Industry
Articles by Category - Regulatory Affairs

2005 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 | 1995 | 1994 | 1993 | 1992 | 1991 | 1990 | 1989 | 1988 | 1987 | 1986 | 1985 | 1984 | 1983 | 1982 | 1981 | 1980 | 1979

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2005

• (Regulatory Outlook) What You Don’t Know About AIP Can Hurt You, Katherine Leibowitz (MDDI, Nov 2005, p. 46). Keyword: FDA.
• (Regulatory Outlook) The Business of Clinical Trials, Part I: Negotiating Confidentiality, IP, and Publications, Katherine Leibowitz (MDDI, Sep 2005, p. 46). Keywords: Clinical Trials.
• "(Newstrends) EU Devices Directive Changes Not Radical, but Not Insignificant", Maria Fontanazza (MDDI, Sep 2005, p. 20). Keyword: Industry.
• (From the Editors), The Editors (MDDI, Sep 2005, p. 14). Keywords: User Fees.
• (Regulatory Outlook) Organization optimizes regulatory outcomes, Nancy Singer Richard DeRisio (MDDI, Aug 2005, p. 56). Keyword: FDA.
• (Newstrends) Nanotech regulatory path unclear, Erik Swain (MDDI, Aug 2005, p. 27). Keywords: New Technologies.
• (Regulatory Outlook) Medical Device Clinical Trials in Japan, Kiyohito Nakai Martin A. Yahiro (MDDI, Jul 2005, p. 46). Keyword: Testing.
• (WASHINGTON WRAP-UP) Are PMAs Legally Safer Than 510(k)s?, James G. Dickinson (MDDI, Jul 2005, p. 40). Keyword: FDA.
• (Newstrends) Congress May Intervene If GPO Conduct Codes Lack Teeth, Erik Swain (MDDI, Jul 2005, p. 21). Keywords: Group Purchasing Organizations.
• (From the Editors), The Editors (MDDI, Jul 2005, p. 14). Keywords: Convenience Kits.
• (WASHINGTON WRAP-UP) Crawford Nomination Delayed by Affair Probe, James G. Dickinson (MDDI, Jun 2005, p. 36). Keyword: FDA.
• (Newstrends) China’s Regulations, Like Its Market, Becoming More Transparent, Erik Swain (MDDI, Jun 2005, p. 21). Keyword: Industry.
• (From the Editors), The Editors (MDDI, Jun 2005, p. 14). Keyword: MDUFMA.

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2002

• (Cover Story) Understanding the Process Approach of ISO 9000:2000, Curt Flemming (MDDI, Oct 2002, p. 54).
• (News & Analysis) Move Toward PDA-Based Devices Gets Boost from FDA, Jason Thibeault (MDDI, Aug 2002, p. 18). Keyword: FDA.
• (News & Analysis) Looking Beyond Security Issues of Part 11 Compliance, Gregg Nighswonger (MDDI, Jul 2002, p. 21). Keyword: Industry.
• (News & Analysis) FDA User Fees Rise, Fall—Rise Again?, Jim Dickinson (MDDI, Jun 2002, p. 20). Keyword: FDA.
• (First Person) Combination Products: Incrementalism Won't Work, Kshitij Mohan (MDDI, Jun 2002, p. 52).
• (First Person) Combination Products: Incrementalism Won't Work, Kshitij Mohan (MDDI, May 2002, p. 52).
• Using UML to Represent Regulatory Material, Bruce Knoth (MDDI, May 2002, p. 66).
• (News & Analysis) Combination Product Reform to Speed Reviews, Increase Accountability, Robert Drummond (MDDI, Apr 2002, p. 20).
• (First Person) Paul A. Levesque presents his suggestions for new product development, Paul Levesque (MDDI, Apr 2002, p. 36).
• (News & Analysis) Another Organization Targets CMS, Robert Drummond (MDDI, Mar 2002, p. 22).
• (News & Analysis) MDMA Fights GPOs for Clear and Level Playing Field, Robert Drummond (MDDI, Mar 2002, p. 20).
• (First Person) Pamela Bailey Presents AdvaMed's Industry Outlook for 2002, Pamela Bailey (MDDI, Mar 2002, p. 36). Keyword: Industry.

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2001

• (Washington Wrap-Up) Wrong again: Disputes panel decides against FDA, James Dickinson (MDDI, Nov 2001, p. 34).
• (Washington Wrap-Up) Putting PMAs, 510(k)s on a paper diet, James Dickinson (MDDI, Jun 2001, p. 32).
• (Inside MDDI) A reality check for device manufacturers, Robert Drummond (MDDI, Apr 2001, p. 19).
• (Editor's Page) Director's Cut: CDRH Chief Extends Himself, Jon Katz (MDDI, Apr 2001, p. 14).
• (Cover Story) Regulating the Point of Care: The IVD Connectivity Industry Consortium, Alan Reder (MDDI, Apr 2001, p. 63).
• (Human Factors Roundtable Part I: The Regulatory Imperative (MDDI, Jan 2001, p. 158). Keywords: Human Factors.
• (Single-Use Devices) Establishing Substantial Equivalence of Reprocessed Single-Use Devices, David West (MDDI, Jan 2001, p. 134). Keyword: Reprocessing.

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2000

• (Bottom Line) A Practical Guide to FDA's Regulation of Promotion and Advertising on the Internet, Jeffrey Shapiro (MDDI, Jun 2000, p. 62). Keywords: FDA, Internet.
• (Bottom Line) Sticking Point: Sharps Makes, Users Feel Pinch of Needlestick Prevention Initiatives, Scott Reisch (MDDI, May 2000, p. 80). Keyword: Needlestick.

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1999

• (First Person) Medical Technology for the Future: Ensuring Patient Access to Innovation, Ronald Dollens (MDDI, Nov 1999, p. 24). Keywords: FDA Reform.
• (510(k) Paradigm) The Development of a New 510(k) Program, Philip Phillips (MDDI, Jun 1999, p. 151). Keyword: 510(k)s.
• Organizing for Compliance: Reflections 20 Years Later, Richard Manthei (MDDI, Jun 1999, p. 103). Keyword: Compliance.
• (First Person) Global Harmonization and Mutual Recognition Efforts: Keeping Up the Pace, Fred Halverson (MDDI, Apr 1999, p. 24). Keyword: Harmonization.
• (Help Desk) CE Marks/IVD Directive, Computer Issues, and Complaint Rate Data versus, Alan Schwartz (MDDI, Jan 1999, p. 84). Keywords: CE Marking.

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1998

• Using Receipt and Decision Cohort Data to Monitor Premarket Review Activities, Gary Blanken (MDDI, Nov 1998, p. 69). Keywords: Device evaluation.
• (Help Desk) Clarifying Device History Record Issues, Fred Hooten (MDDI, Nov 1998, p. 52). Keyword: QSR.
• (Washington Wrap-Up) Judge Permits Spread of Unapproved Uses Literature, James G. Dickinson (MDDI, Oct 1998, p. 32). Keyword: Labeling.
• (Investigating Device Failure) Handling Reports of Product Use in Incidents Causing Injury or Death, Anita Thibeault (MDDI, Sep 1998, p. 91). Keyword: Reporting.
• (ISO 10993) A Practical Guide to ISO 10993-11: Systemic Effects, Richard Wallin (MDDI, Jul 1998, p. 98). Keywords: ISO 10993.
• The Ever-Changing Roles of a Regulatory Affairs Pro, Jennifer M. Sakurai (MDDI, Apr 1998, p. 17).
• Reengineering at CDRH: A Work of Progress, Jonathan S. Kahan (MDDI, Jan 1998, p. 124). Keywords: FDA Reform.

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1997

• (Washington Wrap-Up) Some Manufacturers to Replace MDRs with Summary Report, James G. Dickinson (MDDI, Nov 1997, p. 40). Keywords: Medical Device Reports.
• (News) FDA Revises Software Policy (MDDI, Nov 1997, p. 21). Keyword: Software.
• (News) Manufacturers Concerned about Petitioners' Motives (MDDI, Nov 1997, p. 20). Keywords: Citizen Petitions.
• Device Companies Explore the Competitive Advantages of Regulation, John Bethune (MDDI, Nov 1997, p. 12). Keyword: Competition.
• Displaying Investigational and Unapproved Medical Devices According to FDA Policy, Jeffrey K. Shapiro (MDDI, Oct 1997, p. 93). Keyword: Advertising.
• Draft Revision of FDA's Medical Device Software Policy Raises Warning Flags, Suzan Onel (MDDI, Oct 1997, p. 82). Keyword: Software.
• CE Marking via Self-Declaration, Hans Haindl (MDDI, Sep 1997, p. 86). Keywords: CE Marking.
• (Washington Wrap-Up) Historic MRA Signed with Europe, James G. Dickinson (MDDI, Sep 1997, p. 52). Keywords: Mutual Recognition Agreements.
• (News) Electronic Signature and Record Regulation--A Bright Idea, Says Industry (MDDI, Sep 1997, p. 21). Keywords: Electronic Signatures.
• (Washington Wrap-Up) FDA Confronts Mutual Recognition Reality, James G. Dickinson (MDDI, Aug 1997, p. 42). Keywords: Mutual Recognition Agreements.
• Canada's Medical Device Industry Faces Cost Pressures, Regulatory Reform, Kevin Murray (MDDI, Aug 1997, p. 32). Keyword: Canada.
• (News) Indiana Council Pens Petition on Advisory Committees (MDDI, Jun 1997, p. 21). Keywords: FDA Guidances.
• A Growing Consensus for Regulatory Reform, John Bethune (MDDI, Jun 1997, p. 12). Keywords: FDA Reform.
• Auditing to Ensure Reliable Clinical Trials, Barry Sall (MDDI, May 1997, p. 197). Keywords: Clinical Trials.
• FDA Contends with Regulating the Internet, Dvorah A. Richman (MDDI, May 1997, p. 153). Keyword: Internet.
• (Washington Wrap-Up) Politics as Usual, James G. Dickinson (MDDI, May 1997, p. 90). Keywords: Congress and FDA Reform.
• (News) Translations Challenge U.S. Manufacturers Entering Foreign Markets (MDDI, May 1997, p. 50). Keywords: International Labeling.
• (News) FDA Lends a Hand to Help Device Manufacturers with Design Controls (MDDI, May 1997, p. 44). Keywords: Design Controls.
• (News) Open Channels Are Key to Regulatory Success, Say Experts (MDDI, May 1997, p. 37). Keyword: FDA.
• A Regulatory Forecast for the Internet, Chris Dray (MDDI, May 1997, p. 16). Keyword: Internet.
• (Washington Wrap-Up) Congress Getting Realistic about FDA, James G. Dickinson (MDDI, Apr 1997, p. 40). Keywords: FDA Reform.
• From the Trenches: An Insider's View of Washington, Jeffrey J. Kimbell (MDDI, Apr 1997, p. 28). Keywords: FDA Reform.
• (News) NIST to Foster Agreement on Voluntary Standards (MDDI, Apr 1997, p. 22). Keyword: Standards.
• (Help Desk) Submitting a 510(k) for Changes in Device Design (MDDI, Mar 1997, p. 163). Keywords: Product Submissions.
• New IDE Manual Clarifies FDA Policy on Clinical Studies, Gerard J. Prud'homme (MDDI, Mar 1997, p. 87). Keywords: Clinical Trials.
• Harmonization Efforts Hit Snag (MDDI, Mar 1997, p. 21). Keywords: Mutual Recognition Agreements.
• Gerard Prud'homme: Blending Two Disciplines Benefits Clients, Sherrie Steward (MDDI, Mar 1997, p. 16). Keywords: Clinical Trials.
• (News) FDA's Third-Party Pilot in Need of Submissions (MDDI, Feb 1997, p. 20). Keywords: Third-Party Reviews.
• Remanufactured Devices: Ensuring Their Safety and Effectiveness, Edward M. Basile (MDDI, Jan 1997, p. 153). Keyword: Remanufacturing.

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1996

• (Washington Wrap-Up) FDA Draws Fire for Home Drug Tests and Laser Approvals, James G. Dickinson (MDDI, Dec 1996, p. 28). Keywords: Device Approvals.
• (News) EU Agreements Set Pace for Global Market Alignment (MDDI, Dec 1996, p. 22). Keywords: Mutual Recognition.
• (News) Canada Revises Medical Device Laws to Ease Harmonization (MDDI, Dec 1996, p. 20). Keyword: Harmonization.
• (Washington Wrap-Up) Canada, EU Experiment with Harmonization, James G. Dickinson (MDDI, Nov 1996, p. 44). Keyword: Standards.
• (News) FDA Gathers Input on Design Control Inspection Strategy (MDDI, Nov 1996, p. 20). Keywords: Design Control.
• (News) FDA Releases Revised GMPs (MDDI, Nov 1996, p. 12). Keyword: GMPs.
• FDA's New MDR Regulations: What Manufacturers Need to Know, Edward M. Basile (MDDI, Oct 1996, p. 89). Keywords: Medical Device Reporting.
• (Washington Wrap-Up) FDA Document Leaks Revisited, James G. Dickinson (MDDI, Oct 1996, p. 54). Keywords: Product Approval.
• (Roundtable) Experts Roundtable: Making the Most of Clinical Trials (MDDI, Sep 1996, p. 75). Keywords: Clinical Trials.
• FDA's New Approach to Export Regulation, Jonathan S. Kahan (MDDI, Sep 1996, p. 68). Keyword: Exporting.
• (News) FDA Launches Pilot Program for Third-Party Device Review (MDDI, Sep 1996, p. 14). Keywords: Product Approval.
• FDA's Enforcement Options in Clinical Trials, Halyna Breslawec (MDDI, Aug 1996, p. 57). Keywords: Clinical Trials.
• (Washington Wrap-Up) FDA Expands into Device Marketing, James G. Dickinson (MDDI, Aug 1996, p. 28). Keyword: Advertising.
• FDA's Resurrected Device Classification Program, Charles H. Kyper (MDDI, Jul 1996, p. 92). Keywords: Device Classification.
• (Washington Wrap-Up) When Cultures Collide: The Summit Story at FDA, James G. Dickinson (MDDI, Jul 1996, p. 40). Keywords: Product Approval.
• Helpful Design Guidance, or Stealth Regulation?, John Bethune (MDDI, Jul 1996, p. 8). Keyword: Guidances.
• Biostatistics and the Analysis of Clinical Data, Richard P. Chiacchierini (MDDI, Jun 1996, p. 49). Keywords: Clinical Trials.
• (Washington Wrap-Up) Rebuilding Device Regulation, James G. Dickinson (MDDI, Jun 1996, p. 32). Keywords: Device Regulation.
• (News) Reform Bills Set for Showdown (MDDI, Jun 1996, p. 14). Keywords: FDA Reform.
• (News) Hurdles to Harmonization: FDA Struggles to Balance Priorities (MDDI, Jun 1996, p. 14). Keyword: Harmonization.
• FDA to Device Companies: Approach the Internet with Caution, John Bethune (MDDI, Jun 1996, p. 8). Keyword: Advertising.
• The Logistics of Conducting Clinical Studies, Frank L. Hurley (MDDI, May 1996, p. 112). Keywords: Clinical Trials.
• (Twenty Years of FDA Device Regulation) FDA and the Device Industry: A Tale of Suspicion, James G. Dickinson (MDDI, May 1996, p. 100). Keywords: FDA Regulation.
• (Twenty Years of FDA Device Regulation) The Demise of Rule Making and the Rise of Guidances, Bradley M. Thompson (MDDI, May 1996, p. 99). Keywords: FDA Regulation.
• (Twenty Years of FDA Device Regulation) FDA Enforcement Policies: A 20-Year Perspective, Larry R. Pilot (MDDI, May 1996, p. 97). Keywords: FDA Regulation.
• (Twenty Years of FDA Device Regulation) A Brief History of FDA Good Manufacturing Practices, W. Fred Hooten (MDDI, May 1996, p. 96). Keywords: FDA Regulation.
• (Twenty Years of FDA Device Regulation) The Changing Role of Education in FDA's Regulation of Medical Devices, John C. Villforth (MDDI, May 1996, p. 94). Keywords: FDA Regulation.
• (Twenty Years of FDA Device Regulation) The Evolution of Biomaterials Liability, James S. Benson (MDDI, May 1996, p. 93). Keywords: FDA Regulation.
• (Twenty Years of FDA Device Regulation) FDA Regulatory Programs: Cooperation and Common Sense Typify A Record of Success, Jonathan S. Kahan (MDDI, May 1996, p. 88). Keywords: FDA Regulation.
• A Global Perspective for the 21st Century, Wallis Weiler Cady (MDDI, May 1996, p. 58). Keywords: Medical Device Reporting.
• (Interview) The Development of the Medical Device Amendments, Peter Barton Hutt (MDDI, May 1996, p. 50). Keywords: Medical Device Amendments.
• (News) Electronic Submissions Aim at Faster FDA Product Reviews (MDDI, May 1996, p. 16). Keywords: Electronic Submissions.
• Current and Future FDA Initiatives in Clinical Trials, Susan Alpert (MDDI, Apr 1996, p. 44). Keywords: Clinical Trials.
• (Washington Wrap-Up) FDA Yields on Text Dissemination, James G. Dickinson (MDDI, Mar 1996, p. 36). Keyword: Advertising.
• (Washington Wrap-Up) When Saving Money Costs Just Too Much, James G. Dickinson (MDDI, Mar 1996, p. 32). Keywords: Product Approval.
• Designing Clinical Trials, Gerard J. Prud'homme (MDDI, Feb 1996, p. 72). Keywords: Clinical Trials.
• (Washington Wrap-Up) MDMA Hits FDA's Tobacco Plan, James G. Dickinson (MDDI, Feb 1996, p. 50). Keywords: Device Regulation.
• (News) FDA to Form Committee on Design Control Inspections (MDDI, Feb 1996, p. 19). Keywords: Design Control.
• (News) FDA Urges Company Policy on Web Use (MDDI, Feb 1996, p. 14). Keyword: Advertising.
• A 510(k) Primer FDA's Premarket Notification Process, Arthur C. Kohler (MDDI, Jan 1996, p. 127). Keywords: Product Approval.
• Revolution by Phases: FDA's Regulation of Investigational Device Exemptions, Jonathan S. Kahan (MDDI, Jan 1996, p. 120). Keywords: Clinical Trials.
• Clinical Trials: An Introduction, Kshitij Mohan (MDDI, Jan 1996, p. 114). Keywords: Clinical Trials.
• (Washington Wrap-Up) FDA Withdraws Laerdal Warning Letter, James G. Dickinson (MDDI, Jan 1996, p. 64). Keywords: Warning Letter.
• (Washington Wrap-Up) Burlington Answers WLF, James G. Dickinson (MDDI, Jan 1996, p. 62). Keyword: Reclassification.
• OSB Takes a New Direction: Collaborative Surveillance, Larry Kessler (MDDI, Jan 1996, p. 48). Keyword: Surveillance.
• (News) Who's Right in the FDA Numbers Game?, Cliff Henke (MDDI, Jan 1996, p. 14). Keywords: Product Approval.
• Lies, Damned Lies, and..., John Bethune (MDDI, Jan 1996, p. 10). Keywords: Product Approval.

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1995

• 510(k) Changes: FDA Tries Again, Robert L. Sheridan (MDDI, Dec 1995, p. 46). Keywords: Device Modifications.
• Human Factors Assume Greater Role in Device Review, Michael E. Wiklund (MDDI, Dec 1995, p. 28). Keywords: Human Factors.
• (News) Device Groups Reach Consensus on FDA Reform Legislation (MDDI, Dec 1995, p. 12). Keywords: FDA Reform.
• FDA Regulation of Medical Device Reuse, Jonathan S. Kahan (MDDI, Nov 1995, p. 62). Keywords: Medical Device Reuse.
• (Interview) Speeding toward a Third-Party Future?, Susan Alpert (MDDI, Nov 1995, p. 28). Keywords: Review Process.
• (News) Spring Release Expected for Revised GMP and Guidances (MDDI, Nov 1995, p. 12). Keyword: GMPs.
• (Washington Wrap-Up) Pilot Reviews Elicit Skepticism, James G. Dickinson (MDDI, Oct 1995, p. 51). Keywords: Product Approvals.
• (Washington Wrap-Up) User Fees Shorten Drug Review Times, James G. Dickinson (MDDI, Oct 1995, p. 50). Keywords: User Fees.
• Misguided Export Policy, Judd Gregg (MDDI, Oct 1995, p. 42). Keyword: Exports.
• (News) AAMI Moving Forward with Certification Program (MDDI, Oct 1995, p. 18). Keyword: GMPs.
• Do Bureaucracy and Innovation Mix?, John Bethune (MDDI, Oct 1995, p. 8). Keywords: Design Control.
• Medical Device Regulatory Requirements for Electromagnetic Compatibility, Jonathan S. Kahan (MDDI, Sep 1995, p. 86). Keyword: EMC/EMI.
• FDA's New GMP Working Draft: Industry's Last Chance for Comment, W. Fred Hooten (MDDI, Sep 1995, p. 72). Keyword: GMPs.
• (Washington Wrap-Up) Agency Seeks Redesign of Electrode Lead-Wire Devices, James G. Dickinson (MDDI, Sep 1995, p. 56). Keywords: Performance Standards.
• (Washington Wrap-Up) Advertisers Prefer FTC to FDA, James G. Dickinson (MDDI, Sep 1995, p. 55). Keyword: Marketing.
• (Washington Wrap-Up) Gram Heads Senate Medical Technology Caucus, James G. Dickinson (MDDI, Sep 1995, p. 54). Keyword: Congress.
• (Washington Wrap-Up) Wyden Bill Seeks to 'Improve and Advance' FDA, James G. Dickinson (MDDI, Sep 1995, p. 52). Keyword: Legislation.
• (Washington Wrap-Up) HIMA Turns Up the Heat, James G. Dickinson (MDDI, Sep 1995, p. 52). Keywords: FDA Reform.
• Third-Party Review: Great Ideas Need Time to Mature, John Bethune (MDDI, Sep 1995, p. 8). Keywords: Product Approval.
• (Washington Wrap-Up) Third-Party 510(k) Reviews, James G. Dickinson (MDDI, Aug 1995, p. 46). Keywords: Product Approval.
• (Washington Wrap-Up) HIMA: Abolish Most 510(k)s, James G. Dickinson (MDDI, Aug 1995, p. 46). Keywords: Product Approval.
• Preamendment Class III Devices: The FDA Strategy, Charles H. Kyper (MDDI, Jul 1995, p. 100). Keyword: Reclassification.
• (Washington Wrap-Up) FDA Suffers Historic Loss, James G. Dickinson (MDDI, Jul 1995, p. 40). Keyword: Labeling.
• (Interview) Congress Is as Congress Does, Wayne Barlow (MDDI, Jul 1995, p. 28). Keywords: FDA Reform.
• FDA Reform: Fact or Fiction?, Jonathan S. Kahan (MDDI, Jul 1995, p. 20). Keywords: FDA Reform.
• (News) Device Community Struggles for Harmony on FDA Reform (MDDI, Jul 1995, p. 12). Keywords: FDA Reform.
• (Washington Wrap-Up) Medical Devices for USP?, James G. Dickinson (MDDI, May 1995, p. 67). Keywords: Product Information.
• (Washington Wrap-Up) FDA Looks at Symbols for Labeling, James G. Dickinson (MDDI, May 1995, p. 66). Keyword: Labeling.
• (Washington Wrap-Up) HIMA's Ideas for Fixing FDA, James G. Dickinson (MDDI, May 1995, p. 64). Keywords: FDA Reform.
• (Washington Wrap-Up) Relief for Device Exports, James G. Dickinson (MDDI, Apr 1995, p. 28). Keyword: Exports.
• (News) AAMI Developing Certification Program for GMP Consultants (MDDI, Apr 1995, p. 10). Keyword: GMPs.
• Should Regulations Be Undone, or Redone?, John Bethune (MDDI, Apr 1995, p. 8). Keywords: FDA Reform.
• (Washington Wrap-Up) Unapproved Device Shipments--Pro and Con, James G. Dickinson (MDDI, Mar 1995, p. 44). Keyword: Exports.
• (Washington Wrap-Up) Drug User Fees a Success, James G. Dickinson (MDDI, Mar 1995, p. 40). Keywords: User Fees.
• (Guest Editorial) Reinventing the Environment for Innovation, William W. George (MDDI, Feb 1995, p. 24). Keywords: Regulatory Climate.
• (News) Revised GMP Delayed Again (MDDI, Feb 1995, p. 10). Keyword: GMPs.
• The Role of Labeling in the Compliant Use of Medical Devices, James R. Callan (MDDI, Jan 1995, p. 202). Keyword: Labeling.
• FDA Criminal Prosecutions: New Trends and Old Problems, Jonathan S. Kahan (MDDI, Jan 1995, p. 101). Keyword: Enforcement.
• (News) FDA Policy on Off-Label Training Fuels Debate (MDDI, Jan 1995, p. 14). Keyword: Labeling.

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1994

• (Washington Wrap-Up) Petition Seeks Saline Implant Limits, James G. Dickinson (MDDI, Nov 1994, p. 32). Keywords: Product Restrictions.
• (Washington Wrap-Up) Pedicle Screws for Class II for Two Uses Only, James G. Dickinson (MDDI, Nov 1994, p. 32). Keyword: Reclassification.
• (Washington Wrap-Up) Hatch to the Rescue, James G. Dickinson (MDDI, Nov 1994, p. 28). Keyword: Legislation.
• (Guest Editorial) Taxation without Representation: The Case against FDA User Fees, Thomas C. Thompson (MDDI, Nov 1994, p. 22). Keywords: User Fees.
• Biocompatibility Concerns and Premarket Submissions, Jonathan S. Kahan (MDDI, Oct 1994, p. 94). Keyword: Biocompatibility.
• (Washington Wrap-Up) Johnson Defends FDA's Experts, James G. Dickinson (MDDI, Oct 1994, p. 66). Keyword: Enforcement.
• (Washington Wrap-Up) Unforeseen Downside to User Fees, James G. Dickinson (MDDI, Oct 1994, p. 66). Keywords: User Fees.
• (Washington Wrap-Up) HIMA Buys User Fees--'Without Enthusiasm', James G. Dickinson (MDDI, Oct 1994, p. 64). Keywords: User Fees.
• (Interview) Current Status of GMP Revisions Unveiled, W. Fred Hooten (MDDI, Oct 1994, p. 50). Keyword: GMPs.
• (Guest Editorial) The Adverse Side Effects of FDA's Hearing Aid Prescriptions, Mead C. Killion (MDDI, Oct 1994, p. 42). Keyword: Advertising.
• (Washington Wrap-Up) FDA's 'Secret' Warning Letters, James G. Dickinson (MDDI, Sep 1994, p. 39). Keywords: Freedom of Information.
• (Washington Wrap-Up) Laerdal Wins: Judge Faults FDA Experts, James G. Dickinson (MDDI, Sep 1994, p. 38). Keyword: Enforcement.
• (Washington Wrap-Up) FDA Eyes New Informed-Consent Regulations, James G. Dickinson (MDDI, Sep 1994, p. 36). Keywords: Clinical Investigations.
• (Guest Editorial) Bad-Faith Reviews: The R S Medical Case, James R. Phelps (MDDI, Sep 1994, p. 30). Keyword: 510(k)s.
• How to Prepare for (and Survive) an FDA Inspection, Jim Sandberg (MDDI, Aug 1994, p. 58). Keyword: Inspections.
• 510(k)s for Sale, Bradley Merrill Thompson (MDDI, Aug 1994, p. 34). Keyword: 510(k)s.
• (Washington Wrap-Up) FDA Moving Closer to Hearing Industry, James G. Dickinson (MDDI, Aug 1994, p. 30). Keyword: Advertising.
• (Washington Wrap-Up) Case of the Late Warning Letter, James G. Dickinson (MDDI, Aug 1994, p. 30). Keywords: Warning Letters.
• (Washington Wrap-Up) FDA Loses Customs Bond Seizure Case, James G. Dickinson (MDDI, Aug 1994, p. 28). Keyword: Exports.
• An Inspector Calls, John Bethune (MDDI, Aug 1994, p. 8). Keyword: Inspections.
• Managing Regulatory Submissions for Device Modifications (Revisited), Robert Sheridan (MDDI, Jul 1994, p. 36). Keywords: Device Modifications.
• (Washington Wrap-Up) User Fees Make FDA Listen, James G. Dickinson (MDDI, Jul 1994, p. 30). Keywords: User Fees.
• Washington Wrap-up: NMC in Trouble Again over Bloodlines Supply, James G. Dickinson (MDDI, Jun 1994, p. 48). Keywords: Washington Wrap-up.
• Washington Wrap-up: Press Use of FDA Report Spurs Suit against Bard, James G. Dickinson (MDDI, Jun 1994, p. 48). Keywords: Washington Wrap-up.
• (Washington Wrap-Up) NMC in Trouble Again over Bloodlines Supply, James G. Dickinson (MDDI, Jun 1994, p. 48). Keyword: Enforcement.
• Washington Wrap-up: More Inforation Seen as Cost Curb, James G. Dickinson (MDDI, Jun 1994, p. 46). Keywords: Washington Wrap-up.
• (Washington Wrap-Up) Component Suppliers under FDA Rule, James G. Dickinson (MDDI, Jun 1994, p. 44). Keyword: GMPs.
• Washington Wrap-up: Component Suppliers under FDA Rule, James G. Dickinson (MDDI, Jun 1994, p. 44). Keywords: Washington Wrap-up.
• Washington Wrap-up: FDA Reviewers Wasting Time?, James G. Dickinson (MDDI, Jun 1994, p. 44). Keywords: Washington Wrap-up.
• (Interview) Medical Technology Caucus Rallies Congressional Support for Device Industry, Jim Ramstad (MDDI, Jun 1994, p. 38). Keyword: Congress.
• A New Era for Clinical Studies of Medical Devices, C. Stephen Lawrence (MDDI, May 1994, p. 152). Keywords: Clinical Investigations.
• Medical Device Labeling: Evaluating the Adequacy of Warnings and Instructions, Kenneth Ross (MDDI, May 1994, p. 148). Keyword: Labeling.
• FDA's Revised GMP Regulation: The Road to Global Improvement?, Jonathan S. Kahan (MDDI, May 1994, p. 128). Keyword: GMPs.
• Preparing for FDA's Postmarket Surveillance Requirements, Donald E. Segal (MDDI, May 1994, p. 76). Keywords: Postmarket Surveillance.
• (Washington Wrap-Up) Intraocular Fluid, Promotional Material Seized, James G. Dickinson (MDDI, May 1994, p. 72). Keyword: Marketing.
• (Washington Wrap-Up) FDA Civil Penalties, James G. Dickinson (MDDI, May 1994, p. 70). Keyword: Enforcement.
• (Washington Wrap-Up) A Matter of 'Attitude Adjustment', James G. Dickinson (MDDI, May 1994, p. 66). Keywords: Government-Industry Cooperation.
• (News) Consultants Stew over FDA Efforts to Regulate Them (MDDI, May 1994, p. 24). Keyword: GMPs.
• Are You Scientifically Correct?, John Bethune (MDDI, May 1994, p. 10). Keyword: Science.
• (Washington Wrap-Up) Potential Problems in MEDWatch, James G. Dickinson (MDDI, Apr 1994, p. 30). Keywords: Medical Device Reporting.
• (Washington Wrap-Up) CDRH Analyzes Device Recalls, James G. Dickinson (MDDI, Apr 1994, p. 28). Keyword: Recalls.
• (Washington Wrap-Up) FDA Rules Too Costly for Puritan-Bennett, James G. Dickinson (MDDI, Apr 1994, p. 26). Keywords: FDA Enforcement.
• (Washington Wrap-Up) Overzealous Sales Pitch Retracted, James G. Dickinson (MDDI, Mar 1994, p. 45). Keyword: Marketing.
• (Washington Wrap-Up) HIMA Opposes Hemodialyzer Reuse Guidance, James G. Dickinson (MDDI, Mar 1994, p. 45). Keyword: Reuse.
• (Washington Wrap-Up) When FDA Refuses to Accept, James G. Dickinson (MDDI, Mar 1994, p. 44). Keyword: 510(k)s.
• (Washington Wrap-Up) Discretionary Flexibility, James G. Dickinson (MDDI, Mar 1994, p. 44). Keyword: Guidelines.
• (Washington Wrap-Up) Fear of FDA: How Justified?, James G. Dickinson (MDDI, Mar 1994, p. 42). Keywords: Industry Opinion.
• (Guest Editorial) Optimum Science for Product Review--An Industry Perspective, James S. Benson (MDDI, Mar 1994, p. 28). Keywords: Product Approval.
• Industry, FDA, and the Voice of Reason, John Bethune (MDDI, Mar 1994, p. 8). Keyword: GMPs.
• (Washington Wrap-Up) FDA Faces Possible Lawsuit on Promotion Curbs, James G. Dickinson (MDDI, Feb 1994, p. 38). Keyword: Advertising.
• (Washington Wrap-Up) FDA Willing to Discuss Dialyzer Reuse, James G. Dickinson (MDDI, Feb 1994, p. 37). Keyword: Reuse.
• (Washington Wrap-Up) FDA Clarifies Rules for Foreign Data Sharing, James G. Dickinson (MDDI, Feb 1994, p. 37). Keywords: Freedom of Information.
• Medical Device Labeling: A Comprehensive Approach, Kenneth Ross (MDDI, Jan 1994, p. 106). Keyword: Labeling.
• (Washington Wrap-Up) Medtronic Endorses User Fees, James G. Dickinson (MDDI, Jan 1994, p. 61). Keywords: User Fees.
• (Washington Wrap-Up) Heparin Analyzer Reclassified, James G. Dickinson (MDDI, Jan 1994, p. 60). Keyword: Reclassification.
• (Washington Wrap-Up) Should Device Inventors Design Clinical Trials?, James G. Dickinson (MDDI, Jan 1994, p. 58). Keywords: Clinical Investigations.
• (Washington Wrap-Up) Clinton's Green Light to New Regulations, James G. Dickinson (MDDI, Jan 1994, p. 56). Keywords: Regulatory Climate.
• (Washington Wrap-Up) Clinton Loosens Reins on Secrets, James G. Dickinson (MDDI, Jan 1994, p. 54). Keywords: Freedom of Information.
• (Washington Wrap-Up) FDA Seeks Quick, 'Temporary' PMA Suspensions, James G. Dickinson (MDDI, Jan 1994, p. 52). Keyword: PMA.
• (Washington Wrap-Up) Executives in Handcuffs, James G. Dickinson (MDDI, Jan 1994, p. 48). Keyword: Enforcement.
• (News) Proposed Revisions to GMP Released (MDDI, Jan 1994, p. 16). Keyword: GMPs.

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1993

• Washington Wrap-Up: HIMA Accepts User Fees, but...; Log On to FDA Guidance; Alpert Impresses; FDA's First Civil Money Penalties; Tighter Hearing Aid Rules, James G. Dickinson (MDDI, Dec 1993, p. 20). Keywords: User Fees.
• Medical Device Exports: Navigating FDA's Regulations, Jonathan S. Kahan (MDDI, Nov 1993, p. 82). Keywords: Regulations, Exports.
• Washington Wrap-Up: Faster Device Approvals?; Menace of Civil Penalties; Aneurysm Clip Alert; Paper on a Stick=Device; Final Tracking Rule, James G. Dickinson (MDDI, Nov 1993, p. 34). Keywords: Diagnostics, FDAEnforcement, Product Approvals, Device Tracking, Safety Alert.
• News: Electronic Signature Reg Nears Completion (MDDI, Nov 1993, p. 12). Keywords: Electronic Signatures.
• Last Word on User Fees (The), John Bethune (MDDI, Nov 1993, p. 8). Keywords: User Fees, HIMA.
• Keys to Calibration, Wallis Weiler Cady (MDDI, Oct 1993, p. 122). Keyword: GMPs.
• How to Manage Regulatory Submissions for Device Modifications, Robert Sheridan (MDDI, Oct 1993, p. 64). Keyword: 510(k)s.
• Washington Wrap-Up: FDA Monetary Penalties: How Fair?; Enforcement is Job One at FDA; FDA Teleconferes with Industry; J&J Research Deficiencies at Scripps Cited; Down-Classify Cardiopulmonary Bypass Pumps?, James G. Dickinson (MDDI, Oct 1993, p. 44). Keywords: FDAEnforcement, Classification, Government-Industry Relations, SMDA, Warning Letter.
• News: Device Center Study Cites Common GMP Problems (MDDI, Oct 1993, p. 10). Keywords: CDRH, GMPs.
• Health-Care Reform Reality (The), John Bethune (MDDI, Oct 1993, p. 8). Keywords: Health-Care Reform.
• Simple Checklist for Validation Reports (A), Gale E. Van Buskirk (MDDI, Sep 1993, p. 122). Keyword: GMPs.
• Speeding the Snail's Pace: FDA's New Review Policies, Howard M. Holstein (MDDI, Sep 1993, p. 52). Keywords: Product Approval.
• FDA Notes: Implementing FDA's New Device Tracking Regulation, Donald E. Segal (MDDI, Sep 1993, p. 44). Keywords: Device Tracking.
• Washington Wrap-Up: Reluctant OK for User Fees (A); Committee Report Supports Burlington; Recommendations for Reform; 510(k) Status Reporting System; FDA Moves against Sterilants; Changes at CDRH, James G. Dickinson (MDDI, Sep 1993, p. 38). Keywords: CDRH, FDAEnforcement, 510(k), User Fees, Government Criticism, Personnel.
• News: HIMA Offers Device Tracking Guidance (MDDI, Sep 1993, p. 12). Keywords: Device Tracking.
• Washington Wrap-Up: Sensible Approach to 510(k) Notifications (A); No New Evidence; 'Migrating Particles' Worry FDA Again, James G. Dickinson (MDDI, Aug 1993, p. 34). Keyword: FDAEnforcement.
• Using Process Control Charts to Improve GMP Compliance, Ken Imler (MDDI, Jul 1993, p. 114). Keyword: GMPs.
• Washington Wrap-Up: Drug-Model Warning Letters Hit Device Advertising; Female Condom Publicity Rebutted, James G. Dickinson (MDDI, Jul 1993, p. 38). Keywords: Advertising, Warning Letter.
• News: Industry Members Support User Fees for Product Reviews (MDDI, Jul 1993, p. 10). Keywords: User Fees.
• Evaluating GMP Training Consultants, Lisa Peterson (MDDI, Jun 1993, p. 128). Keyword: GMPs.
• How CLIA May Affect the Agency and the Industry: An Interview with Thomas Tsakeris, Thomas Tsakeris (MDDI, Jun 1993, p. 60). Keywords: FDAEnforcement, CLIA88.
• CLIA's Impact: Trouble Brewing for IVD Clearances?, Julie Zawisza (MDDI, Jun 1993, p. 55). Keyword: CLIA88.
• Commercialization of Unapproved IVDs: Manufacturer Response to Emerging FDA Policy, Patricia Shrader (MDDI, Jun 1993, p. 52). Keyword: Commercialization.
• Washington Wrap-Up: HIMA Rethinks User Fees for Device Applications; Andersen and Tsakeris Resign; What Constitutes Substantial Equivalence?, James G. Dickinson (MDDI, Jun 1993, p. 34). Keywords: User Fees, Regulations, FDAStaffing.
• Face to Face: New Directions for FDA's Device Center?: An Interview with Bruce Burlington, MD, director, CDRH, Bruce Burlington (MDDI, Jun 1993, p. 26). Keyword: CDRH.
• News: FDA's Ombudsman Passed Over in Center Turf Wars (MDDI, Jun 1993, p. 12). Keywords: Combination Devices.
• News: Device Law Pioneer Dies, Larry R. Pilot (MDDI, Jun 1993, p. 10).
• News: Son of Temple: CDRH Plans Follow-up Study (MDDI, Jun 1993, p. 10). Keywords: Clinical Studies.
• Are User Fees Inevitable?, John Bethune (MDDI, Jun 1993, p. 8). Keywords: User Fees.
• Determining Substantial Equivalence: New Challenges in the 510(k) Process, Jonathan S. Kahan (MDDI, May 1993, p. 82). Keyword: 510(k)s.
• RBRVS--The Latest Battlefield in the Medical Technology-Reimbursement War, Gordon B. Schatz (MDDI, May 1993, p. 76). Keyword: Reimbursement.
• FDA's Expanding Definition of Diagnostic Devices, Bradley Merrill Thompson (MDDI, May 1993, p. 58). Keywords: In Vitro Diagnostics.
• Washington Wrap-Up: Kessler Meets HIMA: A Thaw?; Allen Out, Raab In at HIMA; HIMA Challenges FDA on Promotion; FDA on Cellular Phones, James G. Dickinson (MDDI, May 1993, p. 54). Keywords: Industry Relations, Government, Risk Assessment, HIMA.
• Face to Face: Improved Science on Limited Resources: Breaking the Gridlock at ODE: An Interview with James Benson, Senior Vice President for Technology & Regulatory Affairs, HIMA, Washington, DC, James Benson (MDDI, May 1993, p. 42). Keywords: Material Toxicity, Product Approval.
• News: CDRH and HIMA at Odds over Temple Report Findings (MDDI, May 1993, p. 20). Keywords: CDRH, Clinical Investigations.
• Slow Road: FDA Progress on Implementing SMDA (A), Howard M. Holstein (MDDI, Apr 1993, p. 57). Keyword: SMDA.
• Washington Wrap-Up: Kessler Retained; FDA to the Rescue; FDA Can Be Dangerous, Too; Temple Committee Findings; Erroneous Report on Breast Implants; FDA Unbound; Straight Talk from FDA, James G. Dickinson (MDDI, Apr 1993, p. 44). Keywords: Guidelines, FDAEnforcement, Government Criticism, Criticism Task Forces, Product Liability, Industry Opinion, Personnel, HIMA.
• Guest Editorial: Industry Should Support User Fees, Robert Sheridan (MDDI, Apr 1993, p. 32). Keywords: User Fees.
• News: Upgraded Labeling Proposed for Latex Products (MDDI, Apr 1993, p. 16). Keywords: Labeling, Materials Toxicity.
• New Standards for Clinical Studies, John Bethune (MDDI, Apr 1993, p. 8). Keywords: Criticism Task Forces, Clinical Investigations.
• Simple Checklist for Validation Protocols (A), Gale E. Van Buskirk (MDDI, Mar 1993, p. 110). Keyword: GMPs.
• Washington Wrap-Up: Congressional Involvement: Less or More; More Like Drugs, James G. Dickinson (MDDI, Mar 1993, p. 24). Keywords: Government Intervention, Regulatory Climate.
• News: Paperless FDA? (A) (MDDI, Mar 1993, p. 15). Keyword: Software.
• Washington Wrap-Up: In Benson's Wake; Dingell Oversight; New Indications Bring Warning, James G. Dickinson (MDDI, Feb 1993, p. 30). Keywords: FDAEnforcement, FDAEnformcement.
• News: The Next European Agenda: Action on the Environment (MDDI, Feb 1993, p. 15). Keywords: Environmental Impact.
• News: FDA Drafts a Standards Policy (MDDI, Feb 1993, p. 10). Keyword: Standards.
• Medical Device Reclassification: An Opportunity Ignored, Jonathan S. Kahan (MDDI, Jan 1993, p. 70). Keyword: Reclassification.
• FDA Notes: Promoting Change at CDRH, William D. Appler (MDDI, Jan 1993, p. 58). Keywords: Government-Industry Cooperation.
• Washington Wrap-Up: Good for Lawyers; Kessler and Benson Resign; Review Efficiencies in NIH Link; A Mandatory Recall, James G. Dickinson (MDDI, Jan 1993, p. 50). Keywords: Kessler, Political Influence, FDA, Benson, Recalls, Government-Industry Cooperation.
• Guest Editorial: Do Preapproval Inspections Slow Product Reviews, Ronald M. Johnson (MDDI, Jan 1993, p. 34). Keywords: Premarket Approvals.
• News: Low Profile for the EMC Directive (MDDI, Jan 1993, p. 14). Keywords: Electronic Devices, EEC.
• Class Act (A), John Bethune (MDDI, Jan 1993, p. 10). Keyword: Classification.

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1992

• Washington Wrap-Up: A Conversation with FDA's Alan Andersen, James G. Dickinson (MDDI, Dec 1992, p. 22). Keyword: FDAPolicy.
• News: Pedersen details intercenter work processes (MDDI, Dec 1992, p. 10). Keyword: Organization.
• News: Bush Signs User-Fee Bill--Devices Next? (MDDI, Dec 1992, p. 10). Keywords: User Fees.
• Third-Party Solution (The)?, John Bethune (MDDI, Dec 1992, p. 8). Keyword: FDAPolicy.
• Developing and Maintaining the Device Master Record, Jim Sandberg (MDDI, Nov 1992, p. 62). Keywords: Documentation, Device Master Files.
• Washington Wrap-Up: Fixing What's Broke at FDA; CDRH Reorganization; User-Fee Legislation; Improving Submissions, James G. Dickinson (MDDI, Nov 1992, p. 32). Keywords: Policy, Product Approvals, CDRH, User Fees.
• News: Implant Tracking, Retrieval, and Analysis: A Worthy Investment, MD&DI (MDDI, Nov 1992, p. 22). Keywords: Device Tracking.
• News: Can Communication Overcome FDA Politics?, MD&DI (MDDI, Nov 1992, p. 10). Keywords: Policy, FDAEnforcement.
• Washington Wrap-Up: Making Devices More Like Drugs; Untold stories of MDR abuse, James G. Dickinson (MDDI, Oct 1992, p. 30). Keywords: HRG, FDAEnforcement, Budget Cuts, MDR, Wolfe, Regulatory Climate, HIMA.
• News: HIMA Launches Joint Meetings with FDA, MD&DI (MDDI, Oct 1992, p. 20). Keywords: HIMA, Government-Industry Cooperation.
• FDA's New, Improved Approach to Device Tracking, Bradley Merrill Thompson (MDDI, Sep 1992, p. 34). Keywords: FDAEnforcement, Device Tracking.
• Washington Wrap-Up: Congressional Corrections for Devices; EC, FDA enforcement helps exporters; Patient restraint guidelines; Five more Class III preamendment rules, James G. Dickinson (MDDI, Sep 1992, p. 24). Keywords: FDA Enforcement, Legislation, Classification, Safety, International Affairs, Amendments, SMDA, PMA.
• Uncertain Future for Product Clearances, Jonathan S. Kahan (MDDI, Sep 1992, p. 20). Keywords: FDAEnforcemnt, Product Approval.
• News: Rethinking Tissue Regulation, MD&DI (MDDI, Sep 1992, p. 10). Keywords: GMPs, Transparent Tissue.
• CLIA '88 regulation's effect on labeling (The), Gordon B. Schatz (MDDI, Aug 1992, p. 34). Keywords: CLIA '88.
• Washington Wrap-Up: Curbing device marketers; CDRH tension eases; FDA wants more power, James G. Dickinson (MDDI, Aug 1992, p. 28). Keywords: CDRH, FDA Policy.
• Washington Wrap-Up: Naming names at FDA; Device-science task force; Common sense, Anyone?, James G. Dickinson (MDDI, Jul 1992, p. 36). Keywords: Criticism Task Forces, Labeling, Personnel.
• Reexamining FDA's RAISE program, Kshitij Mohan (MDDI, Jul 1992, p. 32). Keywords: FDA Enforcement, Signigicant Risk, Standards, Risk Assessment.
• News: U.S. industry conceding leadership to other nations, report charges, MD&DI (MDDI, Jul 1992, p. 10). Keyword: Standards.
• News: Device tracking derails (MDDI, Jul 1992, p. 10). Keywords: Device Tracking.
• Computerized medical device tracking: a survey, Dick Landis (MDDI, Jun 1992, p. 103). Keywords: Regulatory Affairs, Device Tracking, Postmarket Surveillance.
• Effects of CLIA '88 on IVD design and marketing, Kicab Castaneda-Mendez (MDDI, Jun 1992, p. 99). Keywords: CLIA88, Manufacturing, QA/QC, Laboratories.
• How the environmental movement is 'greening' the medical device industry, Wayne Rogers (MDDI, Jun 1992, p. 96). Keywords: Environmental Impact, Regulatory Affairs.
• Combination products: FDA's new regulation and intercenter agreements, Jonathan S. Kahan (MDDI, Jun 1992, p. 84). Keywords: Combination Products.
• Educated 'no' (An), William D. Appler (MDDI, Jun 1992, p. 52). Keywords: Regulatory Affairs, Government-Industry Cooperation.
• Washington Wrap-up: Revolution at FDA; Device tracking, James G. Dickinson (MDDI, Jun 1992, p. 42). Keywords: Congressional Hearings, CDRH, Device Tracking, Management.
• Face to face with FDA: an interview with David A. Kessler, MD, Commissioner, FDA, James G. Dickinson (MDDI, Jun 1992, p. 36). Keywords: FDAEnforcement, Risk Assessment.
• News: OSHA blood regulations will affect manufacturers (MDDI, Jun 1992, p. 23). Keywords: AIDS, Occupational Safety.
• News: FDA and devices as political footballs (MDDI, Jun 1992, p. 20). Keywords: Political Influence, Regulatory Climate.
• News: Slower product approvals confirmed (MDDI, Jun 1992, p. 12). Keywords: Product Approval.
• Washington Wrap-up: FDA-HIMA cooperation; Secret service agent at FDA; Siemens cited for minimizing complaints; Device-CME policy, James G. Dickinson (MDDI, May 1992, p. 28). Keywords: Safe Medical Devices Act, Complaints, Warning Letter, Personnel, Postmarket Surveillance, Government-Industry Cooperation.
• Pitfalls of linking GMP inspections to product clearances (The), Jonathan S. Kahan (MDDI, May 1992, p. 20). Keywords: Premarket Approvals, GMPs, Inspections.
• News: HIMA task force urges change in FDA enforcement policies (MDDI, May 1992, p. 10). Keywords: FDAEnforcement, Industry Opinion, Inspections.
• Relationship in crisis (A), John Bethune (MDDI, May 1992, p. 8). Keywords: Competitiveness, Government-Industry Cooperation.
• Sorting through the European rules for electromagnetic compatibility, Gene A. Panger (MDDI, Apr 1992, p. 90). Keywords: Electromagnetic Compatibility, Electronic Devices, European Regulations.
• After the inspection: minimizing the effects of a Form FDA 483 or an inaccurate EIR, Larry R. Pilot (MDDI, Apr 1992, p. 75). Keywords: Regulatory Affairs, Inspections.
• Washington Wrap-up: FDA headed for a fall?; FDA's field out of control?;, James G. Dickinson (MDDI, Apr 1992, p. 28). Keywords: FDAEnforcement, District Offices, Regulatory Climate, Industry Opinion.
• Face to face with FDA: an interview with Philip B. White, Director, Office of Standards and Regulations, CDRH, Cliff Henke (MDDI, Apr 1992, p. 22). Keywords: Harmonization, Standards, International Affairs.
• Lengthy patent terms stifle innovation, Ronald E. Lund (MDDI, Apr 1992, p. 18). Keywords: Patent Term Extension, Innovation, Patents.
• News: Toxicity data base urged (MDDI, Apr 1992, p. 16). Keywords: Biomaterials, Toxicity, Materials Toxicity.
• News: Recycling possible only by manufacturer involvement, says consultant (MDDI, Apr 1992, p. 15). Keywords: Recycling, Packaging.
• News: RAISE escalates industry backlash (MDDI, Apr 1992, p. 10). Keywords: Regulatory Climate, Industry Opinion, Critical Devices.
• IRB Q&A, Samuel Herman (MDDI, Mar 1992, p. 74). Keywords: IRBs, Reimbursement, Informed Consent, Clinical Investigations.
• User facility, distributor, and manufacturer medical device reporting: FDA's proposed new rules, Howard M. Holstein (MDDI, Mar 1992, p. 58). Keywords: User Reporting, Problem Reporting, MDR.
• Washington Wrap-up: When compliance is voluntary; Preapproval inspections for 510(k)s; User reporting rule; International Harmonization, James G. Dickinson (MDDI, Mar 1992, p. 40). Keywords: User Reporting, FDAEnforcement, Harmonization, Compliance, 510(k)s, Management, Inspections.
• Face to face with FDA: an interview with James S. Benson, Director, CDRH, Cliff Henke (MDDI, Mar 1992, p. 30). Keywords: Management, Regulatory Climate.
• News: Market opportunities in health-care reform (MDDI, Mar 1992, p. 12). Keywords: Health-Care Reform, Cost Containment, Health Insurance.
• Zero-risk society (The), John Bethune (MDDI, Mar 1992, p. 8). Keywords: Public Opinion.
• Washington Wrap-up: 'Transitional device' data; First mandatory suspension; Draft guidance surveillance; Drugs of abuse screen; Combination products guidelines, James G. Dickinson (MDDI, Feb 1992, p. 26). Keywords: Diagnostics, Guidelines, FDAEnforcement, Reclassification, Surgical Devices, Combination Products, Hometesting, Postmarket Surveillance.
• Face to face with FDA: an interview with David West, Deputy Director, Office of Device Evaluation, CDRH, Cliff Henke (MDDI, Feb 1992, p. 18). Keywords: ODE, Regulatory Climate, Product Approval.
• News: Proposed GMP changes could undermine quality, industry official says (MDDI, Feb 1992, p. 10). Keywords: Audits, Inspections, GMPs.
• News: Industry wary of user reporting rule (MDDI, Feb 1992, p. 10). Keywords: User Reporting.
• Information overload?, John Bethune (MDDI, Feb 1992, p. 8). Keywords: Editorial Opinion, User Reporting.
• IRB Q&A, Samuel Herman (MDDI, Jan 1992, p. 142). Keywords: IRBs, Clinical Investigations, Informed Consent.
• What FDA can--and cannot--do during an inspection, Larry R. Pilot (MDDI, Jan 1992, p. 69). Keywords: Regulatory Affairs, Inspections.
• Investigational and research use of in vitro diagnostics: FDA's new guidance, Jonathan S. Kahan (MDDI, Jan 1992, p. 66). Keywords: Diagnostics, Regulation.
• New regulatory framework takes shape (The), Trevor McPherson (MDDI, Jan 1992, p. 54). Keywords: Regulations, Exports, Australia.
• ISO 9001 and the upcoming revised GMP regulation, H. Neal Dunning (MDDI, Jan 1992, p. 40). Keywords: Harmonization, GMPs.
• Washington Wrap-up: Early spring? (An); Publicity as Punishment; Device Sterilization, James G. Dickinson (MDDI, Jan 1992, p. 34). Keywords: Sterilization, FDAEnforcement, Standards, Regulatory Climate, Warning Letter.
• FDA's enforcement renaissance and medical devices, Ronald M. Johnson (MDDI, Jan 1992, p. 28). Keywords: FDAEnforcement, Compliance, Regulatory Climate.
• News: More detailed roadmap to the CE mark (A) (MDDI, Jan 1992, p. 12). Keywords: EC92, European Regulations.
• News: New twist in clinical utility debate (MDDI, Jan 1992, p. 12). Keywords: Ob/Gyn Devices, Clinical Utility.

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1991

• Sampling strategies for personal monitoring, Jeremy Bachmann (MDDI, Dec 1991, p. 37). Keywords: Et OExposure, Occupational Safety.
• Checklist accelerates the review of PMA applications, Mary R. Hanna (MDDI, Dec 1991, p. 28). Keywords: Premarket Approvals.
• Washington Wrap-up: FDA draws more fire, James G. Dickinson (MDDI, Dec 1991, p. 25). Keywords: Political Influence, Regulatory Climate, Industry Opinion.
• Washington Wrap-up: Seizures up 30%, James G. Dickinson (MDDI, Dec 1991, p. 24). Keyword: FDAEnforcement.
• Washington Wrap-up: Industry resistance surfaces, James G. Dickinson (MDDI, Dec 1991, p. 22). Keywords: FDAEnforcement, Regulatory Climate, Industry Opinion.
• New way of thinking about FDA (A), John Brown (MDDI, Dec 1991, p. 14). Keywords: Forecasts, Regulatory Climate.
• Index to the future? (An), John Bethune (MDDI, Dec 1991, p. 8). Keyword: Forecasts.
• Washington Wrap-up: Too much specificity, James G. Dickinson (MDDI, Nov 1991, p. 27). Keyword: FOI.
• Washington Wrap-up: Two views of clinical utility, James G. Dickinson (MDDI, Nov 1991, p. 27). Keywords: Clinical Utility.
• Washington Wrap-up: What you must never do, James G. Dickinson (MDDI, Nov 1991, p. 26). Keywords: Political Influence, Product Approval.
• Washington Wrap-up: Publicity as enforcement tool, James G. Dickinson (MDDI, Nov 1991, p. 24). Keyword: FDAEnforcement.
• FDA: moving aggressively toward the future, Louis W. Sullivan (MDDI, Nov 1991, p. 12). Keywords: FDAEnforcement, Management, Product Approval.
• Clinical utility and medical device premarket approval, Jonathan S. Kahan (MDDI, Oct 1991, p. 62). Keywords: Premarket Approvals, Clinical Utility.
• Biological in vitro diagnostics, Amiram Daniel (MDDI, Oct 1991, p. 34). Keywords: Diagnostics, Blood Devices, CBER.
• FDA looks at infusion pumps, C. Kaye Riley (MDDI, Oct 1991, p. 32). Keywords: Infusion Pumps.
• Washington Wrap-up: FDA getting through, James G. Dickinson (MDDI, Oct 1991, p. 28). Keywords: Management, Product Approval, Government-Industry Cooperation.
• Quality and cooperation, John Bethune (MDDI, Oct 1991, p. 8). Keyword: Quality.
• Washington Wrap-up: 'Nauseous rhetoric' of enforcement, James G. Dickinson (MDDI, Sep 1991, p. 97). Keywords: FDAEnforcement, Regulatory Climate.
• IRB Q&A, Samuel Herman (MDDI, Sep 1991, p. 76). Keywords: IRBs, Informed Consent, Clinical Investigations.
• Handling complaints systematically: the right approach, Barry V. Ashar (MDDI, Sep 1991, p. 53). Keywords: Complaints, Product Complaints.
• SMDA: certify and summarize, H. Neal Dunning (MDDI, Sep 1991, p. 30). Keywords: Safe Medical Devices Act, 510(k)s.
• Washington Wrap-up: First warning letters issued, James G. Dickinson (MDDI, Sep 1991, p. 24). Keywords: FDAEnforcement, Warning Letter.
• Fences or ambulances: choosing preventive solutions for patient and provider safety, Norman F. Estrin (MDDI, Sep 1991, p. 10). Keyword: Safety.
• SafeMed: Provide or promise, H. Neal Dunning (MDDI, Aug 1991, p. 30). Keywords: Safe Medical Devices Act, Compliance, 510(k)s.
• Washington Wrap-up: Contract manufacturing, James G. Dickinson (MDDI, Aug 1991, p. 26). Keywords: Terminology, Contract Manufacturing.
• Washington Wrap-up: New FDA policies, James G. Dickinson (MDDI, Aug 1991, p. 24). Keywords: Policy, CDRH, Product Approval.
• Washington Wrap-up: Finding a balance, James G. Dickinson (MDDI, Aug 1991, p. 24). Keywords: Regulatory Climate, Industry Opinion.
• Washington Wrap-up: Enforcement methods expand, James G. Dickinson (MDDI, Aug 1991, p. 22). Keyword: FDAEnforcement.
• Washington Wrap-up: Goodby, regulatory letter, James G. Dickinson (MDDI, Jul 1991, p. 22). Keywords: FDAEnforcement, Regulatory Letter, Warning Letter.
• Washington Wrap-up: Shiley, Inc.: a case in point?, James G. Dickinson (MDDI, Jul 1991, p. 22). Keyword: FDAEnforcement.
• Washington Wrap-up: More FDA saber rattling, James G. Dickinson (MDDI, Jul 1991, p. 20). Keyword: FDAEnforcement.
• Enforcement horror stories catch CEOs unprepared, Cheryl Doriot (MDDI, Jul 1991, p. 8). Keywords: Regulatory Climate.
• IRB Q&A, Samuel Herman (MDDI, Jun 1991, p. 170). Keywords: IRBs, Commercialization, Informed Consent.
• FDA restrictions on the commercialization of investigational devices, Jonathan S. Kahan (MDDI, Jun 1991, p. 80). Keywords: Commercialization, IDEs.
• Dealing with FDA when enforcement activities intensify, William D. Appler (MDDI, Jun 1991, p. 34). Keyword: FDAEnforcement.
• Washington Wrap-up: Device labeling, James G. Dickinson (MDDI, Jun 1991, p. 32). Keywords: Terminology, Labeling.
• Washington Wrap-up: Kessler gets tough, James G. Dickinson (MDDI, Jun 1991, p. 30). Keywords: FDAEnforcement, Management.
• Industry at a crossroads (An), David M. Link (MDDI, Jun 1991, p. 16). Keywords: Regulatory Affairs, Regulatory Climate, Industry Opinion.
• Cost of noncompliance goes up (The), Cheryl Doriot (MDDI, Jun 1991, p. 8). Keywords: Regulatory Affairs, Regulatory Climate.
• Washington Wrap-up: FDA criminal investigators, James G. Dickinson (MDDI, May 1991, p. 26). Keyword: FDAEnforcement.
• Washington Wrap-up: Getting priority review, James G. Dickinson (MDDI, May 1991, p. 22). Keywords: Breakthrough Devices, Product Approval.
• CE mark (The): a Pandora's box, Cheryl Doriot (MDDI, May 1991, p. 8). Keywords: European Regulations, Product Approval.
• Putting the squeeze on Medicare reimbursement, Robert F. Leibenluft (MDDI, Apr 1991, p. 43). Keywords: Reimbursement, Outpatient Treatments.
• Implant tracking, surveillance, and retrieval, Elaine Duncan (MDDI, Apr 1991, p. 30). Keywords: Implants, Safe Medical Devices Act.
• Washington Wrap-up: Clarifying a 'clarification', James G. Dickinson (MDDI, Apr 1991, p. 22). Keywords: Surgical Devices, Labeling.
• Law that challenges our resilience (A), Kshitij Mohan (MDDI, Apr 1991, p. 14). Keywords: Safe Medical Devices Act, Industry Opinion.
• ISO 9001 and looking to the future, Cheryl Doriot (MDDI, Apr 1991, p. 8). Keyword: GMPs.
• IRB Q&A, Samuel Herman (MDDI, Mar 1991, p. 96). Keywords: IRBs, Informed Consent, Clinical Investigations.
• Good guys, bad guys, and device reviews, William D. Appler (MDDI, Mar 1991, p. 32). Keywords: Policy, FDAEnforcement.
• Medicare coverage for technology: new dimensions from the courts and Congress, Gordon B. Schatz (MDDI, Mar 1991, p. 26). Keyword: Reimbursement.
• Washington Wrap-up: Paperwork reduction, James G. Dickinson (MDDI, Mar 1991, p. 22). Keyword: Exports.
• Washington Wrap-up: FDA praises Shiley, James G. Dickinson (MDDI, Mar 1991, p. 22). Keywords: Safety Alert.
• Washington Wrap-up: Debarment bill unnecessary?, James G. Dickinson (MDDI, Mar 1991, p. 21). Keywords: FDAEnforcement, Legislation.
• Washington Wrap-up: More enforcement (again), James G. Dickinson (MDDI, Mar 1991, p. 20). Keywords: Kessler, Regulatory Climate.
• Using outcomes to redefine cost containment, Ben L. Holmes (MDDI, Mar 1991, p. 12). Keywords: Cost Containment, Outcomes.
• Washington Wrap-up: Goodbye, presubmission review, James G. Dickinson (MDDI, Feb 1991, p. 68). Keyword: FOI.
• Implications of the Safe Medical Devices Act of 1990 (The), Jonathan S. Kahan (MDDI, Feb 1991, p. 44). Keywords: FDAEnforcement, Safe Medical Devices Act, Regulatory Affairs.
• Washington Wrap-up: Electromedical classification, James G. Dickinson (MDDI, Feb 1991, p. 29). Keywords: Electronic Devices, Classification.
• Washington Wrap-up: Independent sampling of 510(k)s, James G. Dickinson (MDDI, Feb 1991, p. 29). Keyword: 510(k)s.
• Washington Wrap-up: How industry got shut out, James G. Dickinson (MDDI, Feb 1991, p. 24). Keywords: Safe Medical Devices Act, Political Influence, Regulatory Climate.
• IRB Q&A, Samuel Herman (MDDI, Jan 1991, p. 144). Keywords: IRBs, Informed Consent, Clinical Investigations.
• Safe Medical Devices Act of 1990 (The), Jonathan S. Kahan (MDDI, Jan 1991, p. 66). Keywords: Safe Medical Devices Act.
• Getting the most from your patents, Barbara J. Luther (MDDI, Jan 1991, p. 46). Keywords: Patent Term Extension, Patents.
• Who bears the responsibility when device companies violate the law?, William D. Appler (MDDI, Jan 1991, p. 38). Keyword: FDAEnforcement.
• Washington Wrap-up: For the record, James G. Dickinson (MDDI, Jan 1991, p. 34). Keyword: FDAEnforcement.
• Washington Wrap-up: Expanding 'regulatory stream' (The), James G. Dickinson (MDDI, Jan 1991, p. 32). Keywords: Technology Assessment, Product Approval.
• Washington Wrap-up: Device law overhaul, James G. Dickinson (MDDI, Jan 1991, p. 30). Keywords: Safe Medical Devices Act.
• Safe Medical Devices Act of 1990 (The): looking back--but moving forward, Alan H. Magazine (MDDI, Jan 1991, p. 18). Keywords: Safe Medical Devices Act, Regulatory Climate, Industry Opinion.
• Safe Medical Devices Act of 1990 (The): the challenge ahead, Larry R. Pilot (MDDI, Jan 1991, p. 14). Keywords: Safe Medical Devices Act, Regulatory Climate, Criticism.
• FDA goals and the course ahead, Louis W. Sullivan (MDDI, Jan 1991, p. 10). Keywords: Forecasts, Public Health Promotion.

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1990

• Washington Wrap-up: Class II for 'shock' devices, James G. Dickinson (MDDI, Dec 1990, p. 27). Keywords: Electroconvulsive Therapy.
• Washington Wrap-up: New fraud policy, James G. Dickinson (MDDI, Dec 1990, p. 25). Keywords: Policy, FDAEnforcement.
• Washington Wrap-up: Regulation confronts technology, James G. Dickinson (MDDI, Dec 1990, p. 22). Keywords: CLIA88, Industry Opinion, Laboratories.
• Washington Wrap-up: Budget woes, James G. Dickinson (MDDI, Dec 1990, p. 22). Keywords: Cost Containment, Budget Cuts.
• New law casts a somber mood, Cheryl Doriot (MDDI, Dec 1990, p. 8). Keywords: Safe Medical Devices Act, Forecasts.
• Hybrid software development model for medical instruments (A), Steven R. Mallory (MDDI, Nov 1990, p. 41). Keywords: Software, Development.
• More on filing supplements for changes in 510(k)'d devices, William D. Appler (MDDI, Nov 1990, p. 30). Keyword: 510(k)s.
• Washington Wrap-up: Measuring therapy outcomes, James G. Dickinson (MDDI, Nov 1990, p. 29). Keyword: Outcomes.
• Washington Wrap-up: No more Mr. Nice Guy, James G. Dickinson (MDDI, Nov 1990, p. 26). Keywords: Regulatory Climate.
• Face to face with FDA: an interview with Robert L. Sheridan, Director, Office of Device Evaluation, CDRH (MDDI, Nov 1990, p. 18). Keywords: Advisory Panels, Product Approval.
• Design controls make sense, Cheryl Doriot (MDDI, Nov 1990, p. 8). Keywords: Design Controls, GMPs.
• GMP for IVDs (The): the second round, Amiram Daniel (MDDI, Oct 1990, p. 38). Keywords: Diagnostics, Regulation, GMPs.
• ODE offers advice on submitting supplements to PMAs, 510(k)s, William D. Appler (MDDI, Oct 1990, p. 32). Keywords: Premarket Approvals.
• Washington Wrap-up: Enforcement report, James G. Dickinson (MDDI, Oct 1990, p. 30). Keyword: FDAEnforcement.
• Washington Wrap-up: HR 3095 analysis, James G. Dickinson (MDDI, Oct 1990, p. 29). Keywords: Safe Medical Devices Act, Legislation.
• Washington Wrap-up: Market exclusivity debate, James G. Dickinson (MDDI, Oct 1990, p. 26). Keywords: Marketing, Legislation.
• Face to face with FDA: an interview with Ann B. Holt, Acting Director, Office of Compliance and Surveillance, CDRH (MDDI, Oct 1990, p. 18). Keywords: FDAEnforcement, MDR, Compliance.
• In defense of the 510(k) process, Ravi Chinta (MDDI, Oct 1990, p. 14). Keywords: 510(k)s, Product Approval.
• Export and import of medical devices: navigating FDA's tougher regulatory waters, Jonathan S. Kahan (MDDI, Sep 1990, p. 54). Keywords: Regulations, Exports, Imports.
• Washington Wrap-up: Why the slowdown?, James G. Dickinson (MDDI, Sep 1990, p. 33). Keywords: Product Approval.
• Washington Wrap-up: Lawbreaking start-ups, James G. Dickinson (MDDI, Sep 1990, p. 30). Keywords: IDEs, Clinical Investigations.
• Face to face with FDA: an interview with Joseph S. Arcarese, Director, Office of Training and Assistance, CDRH (MDDI, Sep 1990, p. 20). Keywords: Public Health Promotion, End-Users, Assistance.
• Technology assessment and outcomes research: the twin peaks of tomorrow's health-care landscape, Edward C. Bessey (MDDI, Sep 1990, p. 10). Keywords: Technology Assessment, Outcomes.
• Lifting the burden of IDE regulations off device feasibility studies, Bradley Merrill Thompson (MDDI, Aug 1990, p. 44). Keywords: IDEs, Research, Feasibility Studies.
• Clearing the approval barrier in Australia, Trevor McPherson (MDDI, Aug 1990, p. 42). Keyword: Australia.
• Washington Wrap-up: O'Connell honored, James G. Dickinson (MDDI, Aug 1990, p. 35). Keywords: Diagnostics, Personnel.
• Washington Wrap-up: FDA debarments?, James G. Dickinson (MDDI, Aug 1990, p. 34). Keywords: FDAEnforcement, Legislation.
• Face to face with FDA: an interview with W. Fred Hooten, Director, Division of Compliance Programs, Office of Compliance and Surveillance (MDDI, Aug 1990, p. 16). Keywords: Compliance, Government-Industry Cooperation, Inspections, GMPs.
• Washington Wrap-up: Clinging to IVD 0.1% SAL, James G. Dickinson (MDDI, Jul 1990, p. 60). Keywords: Diagnostics, Regulation, Sterility Assurance.
• Efficacy testing of antimicrobial agents, Gayle K. Mulberry (MDDI, Jul 1990, p. 50). Keywords: Antimicrobial Agents.
• What device manufacturers need to know, William D. Appler (MDDI, Jul 1990, p. 32). Keywords: Regulatory Affairs, Forecasts, Regulatory Climate.
• Washington Wrap-up: In-use monitoring by FDA, James G. Dickinson (MDDI, Jul 1990, p. 30). Keyword: Gloves.
• News: Health outcomes to dominate device market (MDDI, Jul 1990, p. 23). Keywords: Cost Containment, Reimbursement, Outcomes.
• News: Tougher drug rules may affect devices (MDDI, Jul 1990, p. 22). Keywords: Premarket Approvals, Regulatory Climate.
• Face to face with FDA: an interview with Walter Gundaker, Acting Deputy Director, CDRH (MDDI, Jul 1990, p. 16). Keywords: FDAEnforcement, Legislation, MDR, Assistance.
• No rest for the regulated, Cheryl Doriot (MDDI, Jul 1990, p. 8). Keyword: GMPs.
• Medical device competitors: playing on a level field, Jeffrey N. Gibbs (MDDI, Jun 1990, p. 105). Keywords: Unfair Competition, Lanham Act, FDAEnforcement.
• Clarifying FDA's policy on device modifications, Jonathan S. Kahan (MDDI, Jun 1990, p. 101). Keywords: Premarket Approvals, 510(k)s, IDEs.
• International standards: harmonizing to a European tune, Gary M. Stephenson (MDDI, Jun 1990, p. 97). Keywords: Harmonization, International Affairs, European.
• Australian rules, Trevor McPherson (MDDI, Jun 1990, p. 88). Keywords: International Affairs, Australia.
• Device master files, Stan Stringer (MDDI, Jun 1990, p. 60). Keywords: Device Master Files.
• International regulatory update, Amiram Daniel (MDDI, Jun 1990, p. 52). Keywords: Diagnostics, Regulation, International Affairs.
• FDA and Maryland cooperate on devices, William D. Appler (MDDI, Jun 1990, p. 46). Keywords: International Affairs, Biotechnology.
• Washington Wrap-up: New mailing addresses, James G. Dickinson (MDDI, Jun 1990, p. 44). Keywords: Premarket Approvals, MDR.
• Washington Wrap-up: Flawed endoscope washer design?, James G. Dickinson (MDDI, Jun 1990, p. 42). Keywords: Advertising, Sterilization, Failure Analysis.
• Washington Wrap-up: Unapproved, unreported, James G. Dickinson (MDDI, Jun 1990, p. 42). Keywords: Ob/Gyn Devices.
• Washington Wrap-up: 'Controlling' devices, James G. Dickinson (MDDI, Jun 1990, p. 40). Keywords: Regulatory Climate.
• News: Physician payment reform will affect manufacturers (MDDI, Jun 1990, p. 36). Keywords: Reimbursement, Physicians.
• News: California proposes EtO controls (MDDI, Jun 1990, p. 34). Keywords: Et O, California, Et OResiduals.
• News: Occupational radiation standards may toughen (MDDI, Jun 1990, p. 32). Keywords: Occupational Safety.
• Face to face with FDA: an interview with Elizabeth D. Jacobson, Director, Office of Science and Technology, CDRH, FDA (MDDI, Jun 1990, p. 18). Keywords: Tests, Research, Product Approval.
• EC directives don't spell harmony yet, Kshitij Mohan (MDDI, Jun 1990, p. 10). Keywords: Europe, European Regulations.
• Preserving our spirit of cooperation, Cheryl Doriot (MDDI, Jun 1990, p. 8). Keywords: Cooperation, Government-Industry Cooperation.
• Conformance in a nutshell: assessing adherence to voluntary standards, Eduardo March (MDDI, May 1990, p. 40). Keywords: Voluntary Standards, Classification.
• Medicare's new RVS: manufacturers beware, Ted R. Mannen (MDDI, May 1990, p. 38). Keywords: Reimbursement, Medicare, Physicians.
• FDA Notes: Clinical outcomes and device review, William D. Appler (MDDI, May 1990, p. 33). Keywords: Clinical Investigations, Product Approval.
• FDA Notes: AIDS transmission by medical devices, William D. Appler (MDDI, May 1990, p. 32). Keyword: Reuse.
• FDA Notes: ODE guidance, William D. Appler (MDDI, May 1990, p. 32). Keywords: ODE, Guidelines.
• Washington Wrap-up: Jarvik update, James G. Dickinson (MDDI, May 1990, p. 29). Keywords: Cardiovascular Devices.
• Washington Wrap-up: FDA device corruption?, James G. Dickinson (MDDI, May 1990, p. 27). Keywords: Government Criticism, 510(k)s.
• Washington Wrap-up: Eleven GMP observations, James G. Dickinson (MDDI, May 1990, p. 27). Keywords: FDAEnforcement, GMPs.
• Washington Wrap-up: Shiley showed MDR's importance, James G. Dickinson (MDDI, May 1990, p. 26). Keyword: MDR.
• Washington Wrap-up: Datascope, a case in point, James G. Dickinson (MDDI, May 1990, p. 24). Keyword: FDAEnforcement.
• Washington Wrap-up: Focus on enforcement, James G. Dickinson (MDDI, May 1990, p. 24). Keyword: FDAEnforcement.
• New rules for a new decade, Trevor McPherson (MDDI, Apr 1990, p. 44). Keyword: Australia.
• Proficiency testing, Amiram Daniel (MDDI, Apr 1990, p. 34). Keywords: Diagnostics, Proficiency Testing.
• Enforcement review, 1989, William D. Appler (MDDI, Apr 1990, p. 30). Keyword: FDAEnforcement.
• Washington Wrap-up: Withdrawal of Jarvik heart's IDE, James G. Dickinson (MDDI, Apr 1990, p. 27). Keywords: FDAEnforcement, Cardiovascular Devices.
• Washington Wrap-up: FDA criminal powers come home, James G. Dickinson (MDDI, Apr 1990, p. 26). Keywords: FDAEnforcement, Trade Secrets, Government Relations.
• Washington Wrap-up: 1980s witnessed a device boom (The), James G. Dickinson (MDDI, Apr 1990, p. 24). Keywords: Premarket Approvals, 510(k)s.
• News: CFC surtax kicks in (MDDI, Apr 1990, p. 19). Keywords: Costs, CFCs.
• News: Consortium to evaluate medical technology (MDDI, Apr 1990, p. 18). Keywords: Cost Containment, Technology Assessment.
• News: FDA publishes R&D 'wish list' (MDDI, Apr 1990, p. 16). Keywords: R&D, Research.
• Cost-effectiveness: new yardstick for medical device evaluation, Gary M. Stephenson (MDDI, Mar 1990, p. 71). Keywords: Cost Containment, Reimbursement, Outcomes.
• FDA regulators in the land of cotton, Miles Weiss (MDDI, Mar 1990, p. 54). Keywords: Southeast, Regulatory Climate.
• Market Report: Emerging medical-waste industry (The), Pieter Halter (MDDI, Mar 1990, p. 48). Keywords: Waste Management, Medical Waste.
• Some free advice for ODE, William D. Appler (MDDI, Mar 1990, p. 36). Keywords: ODE, 510(k)s, Industry Opinion.
• Washington Wrap-up: Pursuing 'clinical benefit', James G. Dickinson (MDDI, Mar 1990, p. 32). Keywords: Premarket Approvals.
• News: Low-level radiation: unsafe at any dose (MDDI, Mar 1990, p. 18). Keywords: Standards, Radiology Devices.
• News: US may ease high-tech controls (MDDI, Mar 1990, p. 18). Keywords: International Trade, Exports.
• Message from the chairman, Jerry E. Robertson (MDDI, Mar 1990, p. 10). Keyword: HIMA.
• IRB Q&A, Samuel Herman (MDDI, Feb 1990, p. 52). Keywords: IRBs, MDR, Clinical Investigations.
• News from the IVD front: Home-use IVDs, Amiram Daniel (MDDI, Feb 1990, p. 34). Keywords: Diagnostics, Home Testing.
• FDA appeals process (The), William D. Appler (MDDI, Feb 1990, p. 30). Keywords: Adverse Decisions, Appeals.
• Washington Wrap-up: Glove adulteration, James G. Dickinson (MDDI, Feb 1990, p. 29). Keyword: Gloves.
• Washington Wrap-up: Hip prostheses into Class II, James G. Dickinson (MDDI, Feb 1990, p. 29). Keywords: Implants, Reclassification.
• Washington Wrap-up: 'Serious problems pervade devices', James G. Dickinson (MDDI, Feb 1990, p. 28). Keywords: Congressional Hearings, Government Criticism.
• Washington Wrap-up: Benson 'rescued', James G. Dickinson (MDDI, Feb 1990, p. 27). Keywords: Political Influence, Management.
• Washington Wrap-up: Safe custody of trade secrets, James G. Dickinson (MDDI, Feb 1990, p. 26). Keywords: Trade Secrets, FOI.
• News: Ultrasound labeling standards coming: fetal Doppler guidelines here (MDDI, Feb 1990, p. 18). Keywords: Ultrasound, Labeling.
• More news on IVDs, Cheryl Doriot (MDDI, Feb 1990, p. 8). Keyword: Diagnostics.
• FDA's 510(k) review procedure for medical devices, Richard R. Scott (MDDI, Jan 1990, p. 62). Keywords: 510(k)s, Product Approval.
• Medical device reporting: compliance and controversy, Jonathan S. Kahan (MDDI, Jan 1990, p. 58). Keywords: Compliance, MDR.
• Perspectives on the 1990s, Greg Freiherr (MDDI, Jan 1990, p. 52). Keywords: Cost Containment, Forecasts, Regulatory Climate.
• Outcomes research: a new revolution waiting in the wings?, George M. Naimark (MDDI, Jan 1990, p. 42). Keywords: Legislation, R&D, Outcomes.
• Radical change in European medical device standards, Mika O. Reinikainen (MDDI, Jan 1990, p. 38). Keywords: Standards, European Regulations.
• Some thoughts on device recalls, William D. Appler (MDDI, Jan 1990, p. 26). Keyword: Recalls.
• Washington Wrap-up: Hip prosthesis technology, James G. Dickinson (MDDI, Jan 1990, p. 25). Keyword: Implants.
• Washington Wrap-up: Preproduction QA guidelines, James G. Dickinson (MDDI, Jan 1990, p. 24). Keywords: Preproduction QA, Guidelines, Software.
• Washington Wrap-up: Huge loss at FDA (A), James G. Dickinson (MDDI, Jan 1990, p. 22). Keywords: Political Influence, Personnel.
• News: Proposition 65 takes aim at medical device manufacturers (MDDI, Jan 1990, p. 18). Keywords: California, Proposition65.
• Challenges for the next decade, Kshitij Mohan (MDDI, Jan 1990, p. 10). Keywords: Legislation, Regulatory Climate.

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1989

• Washington Wrap-up: Hurrying up FDA, Larry Oster (MDDI, Dec 1989, p. 32). Keywords: Ob/Gyn Devices, Standards, Labeling.
• Washington Wrap-up: FDA politicization, Larry Oster (MDDI, Dec 1989, p. 31). Keywords: Political Influence, Personnel.
• Washington Wrap-up: Dingell on the warpath, Larry Oster (MDDI, Dec 1989, p. 28). Keywords: Government Criticism.
• Sheridan shows imagination, competence, William D. Appler (MDDI, Dec 1989, p. 22). Keywords: Product Approval, Government-Industry Cooperation.
• CFC control: more than air conditioners and styrofoam cups, Robert R. Reich (MDDI, Dec 1989, p. 10). Keyword: CFCs.
• Washington Wrap-up: Approval with training, Larry Oster (MDDI, Nov 1989, p. 45). Keywords: Ob/Gyn Devices, Advisory Panels, Product Approval.
• Washington Wrap-up: New FDA (A), Larry Oster (MDDI, Nov 1989, p. 42). Keywords: Safe Medical Devices Act, Political Influence, Regulatory Climate.
• 1989 Waxman-Dingell medical devices bill (The), Howard M. Holstein (MDDI, Nov 1989, p. 34). Keywords: Safe Medical Devices Act, Legislation.
• Will repercussions from generic drugs affect CDRH decision making?, William D. Appler (MDDI, Nov 1989, p. 22). Keywords: CDRH, Product Approval, Personnel.
• Take no prisoners, Cheryl Doriot (MDDI, Nov 1989, p. 8). Keywords: Government Criticism, Industry Opinion.
• FDA regulation of device-drug combinations, Jonathan S. Kahan (MDDI, Oct 1989, p. 58). Keywords: Combination Products.
• Quality control in IVD manufacturing, Andrew J. O'Beirne (MDDI, Oct 1989, p. 52). Keywords: Quality, Manufacturing, QA/QC.
• Washington Wrap-up: Clark Research loses again, Larry Oster (MDDI, Oct 1989, p. 49). Keywords: FDAEnforcement, Product Approval.
• Washington Wrap-up: FDA plant registration fees?, Larry Oster (MDDI, Oct 1989, p. 48). Keywords: Legislation, Registration.
• Washington Wrap-up: All eyes on Europe, Larry Oster (MDDI, Oct 1989, p. 46). Keywords: Standards, International Affairs.
• Market Report: Business health-care costs up 30% in 1988, Pieter Halter (MDDI, Oct 1989, p. 42). Keywords: Insurance, Cost Containment.
• FDA Notes: Elsewhere in court, William D. Appler (MDDI, Oct 1989, p. 37). Keywords: Regulatory Letter.
• FDA Notes: Notes from the courthouse, William D. Appler (MDDI, Oct 1989, p. 36). Keyword: Inspections.
• Non-FDA factors affecting entry into the device market, William D. Appler (MDDI, Oct 1989, p. 30). Keywords: Cost Containment, Reimbursement.
• Waxman is back, Cheryl Doriot (MDDI, Oct 1989, p. 8). Keywords: Safe Medical Devices Act, Industry Opinion.
• IRB Q&A, Samuel Herman (MDDI, Sep 1989, p. 90). Keywords: Significant Risk, HCFA, Clinical Investigations.
• Washington Wrap-up: HRG grist for the mill, Larry Oster (MDDI, Sep 1989, p. 41). Keywords: FDAEnforcement, HRG, MDR.
• Washington Wrap-up: Diagnosis proficiency testing, Larry Oster (MDDI, Sep 1989, p. 41). Keyword: Laboratories.
• Washington Wrap-up: FDA standards compromise, Larry Oster (MDDI, Sep 1989, p. 40). Keywords: Ob/Gyn Devices, Labeling.
• Washington Wrap-up: FDA device scandal? (An), Larry Oster (MDDI, Sep 1989, p. 38). Keywords: Government Criticism, Personnel.
• Designing for 1992, Cheryl Doriot (MDDI, Sep 1989, p. 8). Keywords: Quality, Standards, Certification.
• Working successfully with FDA, Jonathan S. Kahan (MDDI, Aug 1989, p. 42). Keywords: Regulatory Affairs, Compliance, Product Approval.
• Washington Wrap-up: Medical waste, Larry Oster (MDDI, Aug 1989, p. 40). Keywords: Medical Waste.
• Washington Wrap-up: Us against them, part I, Larry Oster (MDDI, Aug 1989, p. 34). Keyword: FDAEnforcement.
• Washington Wrap-up: National health insurance, Larry Oster (MDDI, Aug 1989, p. 34). Keywords: Insurance Coverage.
• Brave new world: a revolution is brewing, Nicholas A. Gallo (MDDI, Aug 1989, p. 12). Keywords: Cost Containment, Reimbursement.
• User fees: debate continues, Cheryl Doriot (MDDI, Aug 1989, p. 8). Keywords: User Fees.
• IRB Q&A, Samuel Herman (MDDI, Jul 1989, p. 48). Keywords: IRBs, Clinical Investigations.
• Clinical Laboratory Improvement Amendments: trouble or opportunity for manufacturers?, Miles Weiss (MDDI, Jul 1989, p. 37). Keywords: CLIA88, Laboratories.
• Washington Wrap-up: More on cost/benefit, Larry Oster (MDDI, Jul 1989, p. 28). Keywords: HRG, Product Approval, Home Testing.
• Washington Wrap-up: User fees again, Larry Oster (MDDI, Jul 1989, p. 26). Keywords: User Fees.
• GAO raises serious questions, William D. Appler (MDDI, Jul 1989, p. 20). Keywords: MDR, Government Criticism.
• GAO's MDR report: few surprises, Cheryl Doriot (MDDI, Jul 1989, p. 8). Keyword: MDR.
• Clinical Research Q&A, Maria M. Koretz (MDDI, Jun 1989, p. 160). Keywords: Efficacy, Product Positioning, Clinical Investigations.
• Auditing by variables analysis: foiling Murphy's Law, Frank M. Gregorio (MDDI, Jun 1989, p. 108). Keywords: Audits, Variables Analysis.
• Medical device investigations: understanding IRB and informed consent requirements, Jeffrey N. Gibbs (MDDI, Jun 1989, p. 103). Keywords: IRBs, Informed Consent, Clinical Investigations.
• FDA: 10 years in retrospect, Larry Oster (MDDI, Jun 1989, p. 95). Keywords: FDAEnforcement, Organization, Assistance.
• Washington Wrap-up: New laser catheter, Larry Oster (MDDI, Jun 1989, p. 68). Keyword: Lasers.
• Washington Wrap-up: Fewer dental x-rays, Larry Oster (MDDI, Jun 1989, p. 68). Keyword: X-Rays.
• Washington Wrap-up: Stun guns are devices, Larry Oster (MDDI, Jun 1989, p. 67). Keywords: Stun Guns.
• Washington Wrap-up: Cost-effective devices, Larry Oster (MDDI, Jun 1989, p. 64). Keywords: Cost Containment, Advisory Panels, Product Approval.
• Where have all the new regulations gone?, Mika O. Reinikainen (MDDI, Jun 1989, p. 46). Keywords: Harmonization, European Regulations, International Affairs.
• Home-use AIDS tests: FDA's dilemma, William D. Appler (MDDI, Jun 1989, p. 36). Keywords: AIDS, Home Testing.
• Statistical presentations for FDA submissions, Steven S. Lewis (MDDI, May 1989, p. 66). Keywords: Documentation, Premarket Approvals, Clinical Investigations.
• FDA regulation of in vitro diagnostic devices, Jonathan S. Kahan (MDDI, May 1989, p. 41). Keywords: Diagnostics, Home Testing.
• Washington Wrap-up: 'Intended' use, Larry Oster (MDDI, May 1989, p. 32). Keywords: FDAEnforcement, Classification.
• Washington Wrap-up: 'Gotcha!' syndrome (The), Larry Oster (MDDI, May 1989, p. 26). Keywords: FDAEnforcement, 510(k)s.
• FDA inspections: advanced strategies, William D. Appler (MDDI, May 1989, p. 18). Keywords: FDAEnforcement, Inspections.
• Washington Wrap-up: Transition blues, Larry Oster (MDDI, Apr 1989, p. 110). Keywords: Political Influence, Personnel.
• Clinical Research Q&A, Maria M. Koretz (MDDI, Apr 1989, p. 98). Keywords: Training, Clinical Investigations, Home Testing.
• Washington Wrap-up: Case against user fees (The), Larry Oster (MDDI, Apr 1989, p. 36). Keywords: User Fees.
• HCFA proposes new regulation for Medicare coverage of new technologies, Gordon B. Schatz (MDDI, Apr 1989, p. 30). Keyword: Reimbursement.
• Benefits of an FDA/academic/industry partnership (The), William D. Appler (MDDI, Apr 1989, p. 22). Keywords: District Offices, Biotechnology, Government-Industry Cooperation.
• American and European standards: the crossroads, John Anderson (MDDI, Apr 1989, p. 14). Keywords: Harmonization, Standards, European.
• HCFA's rising influence, Cheryl Doriot (MDDI, Apr 1989, p. 8). Keyword: HCFA.
• Recall: a second chance, Leonard J. Stauffer (MDDI, Mar 1989, p. 60). Keyword: Recalls.
• Washington Wrap-up: Biotech AIDS kit, Larry Oster (MDDI, Mar 1989, p. 34). Keywords: Diagnostics, AIDS, Biotechnology.
• Washington Wrap-up: 'Device' or a 'novelty'? (A), Larry Oster (MDDI, Mar 1989, p. 33). Keywords: Contraceptives, Classification.
• Washington Wrap-up: Back to basics, Larry Oster (MDDI, Mar 1989, p. 33). Keyword: Compliance.
• Washington Wrap-up: Happy IVD ending (A), Larry Oster (MDDI, Mar 1989, p. 33). Keyword: Inspections.
• Washington Wrap-up: Hatch on devices, Larry Oster (MDDI, Mar 1989, p. 32). Keywords: Political Influence, Legislation, Contact Lens.
• Case of EUCOMED (The), Mika O. Reinikainen (MDDI, Mar 1989, p. 24). Keywords: EUCOMED, Harmonization, European Regulations.
• Assisting the FDA-regulated device industry: the ins and outs, William D. Appler (MDDI, Mar 1989, p. 16). Keywords: Compliance, Consultants, Assistance.
• FDA classifies last device group, Arthur C. Kohler (MDDI, Feb 1989, p. 37). Keyword: Classification.
• Washington Wrap-up: Home-use IVDs, Larry Oster (MDDI, Feb 1989, p. 25). Keywords: Diagnostics, Home Testing.
• Washington Wrap-up: More efficient FDA (A), Larry Oster (MDDI, Feb 1989, p. 22). Keywords: Organization, Government-Industry Cooperation.
• Rationality and FDA litigation, William D. Appler (MDDI, Feb 1989, p. 16). Keyword: FDAEnforcement.
• Washington Wrap-up: Reuse of dialyzers, Larry Oster (MDDI, Jan 1989, p. 117). Keywords: Blood Devices, Reuse.
• Proposition 65: the straw that breaks the camel's back?, Gary M. Stephenson (MDDI, Jan 1989, p. 62). Keywords: California, Proposition65, Regulatory Climate.
• 510(k) notice and device software (The): what is required?, Jonathan S. Kahan (MDDI, Jan 1989, p. 57). Keywords: Software, 510(k)s.
• Washington Wrap-up: Smokeless device, Larry Oster (MDDI, Jan 1989, p. 43). Keywords: Smokeless Cigarettes.
• Washington Wrap-up: Quality of care ascendant, Larry Oster (MDDI, Jan 1989, p. 42). Keyword: Quality.
• Medical plastics: the state of the industry, Jeffrey R. Ellis (MDDI, Jan 1989, p. 32). Keywords: Trends, Medical Waste.
• Exporting reprocessed pacemakers: lessons learned and unresolved, William D. Appler (MDDI, Jan 1989, p. 26). Keywords: Reuse, Exports.
• Mohan on more money for FDA, the deficit, agency predictability, Larry Oster (MDDI, Jan 1989, p. 20). Keywords: Budget Cuts, Product Approval, Industry Opinion.
• Prop 65: debate continues, Cheryl Doriot (MDDI, Jan 1989, p. 8). Keywords: California, Proposition65.

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1988

• Washington Wrap-up: Mohan leaves FDA, Larry Oster (MDDI, Dec 1988, p. 20). Keywords: Mohan, Personnel, Product Approval.
• FDA's 'object all sublime': protecting public health, Kshitij Mohan (MDDI, Dec 1988, p. 10). Keywords: Consumer Affairs, Industry Opinion, Product Approval.
• Washington Wrap-up: Home-care costs going up, Larry Oster (MDDI, Nov 1988, p. 88). Keywords: Cost Containment.
• FDA approves three new products, Miles Weiss (MDDI, Nov 1988, p. 62). Keywords: Ultrasound, Premarket Approvals, Cardiovascular Devices.
• Washington Wrap-up: Devices that need drugs, Larry Oster (MDDI, Nov 1988, p. 44). Keywords: Combination Products.
• Washington Wrap-up: Laboratory quality controls, Larry Oster (MDDI, Nov 1988, p. 44). Keyword: Laboratories.
• News: Latex condoms and accessories: summary of U.S. medical device requirements, Richard Rivera (MDDI, Nov 1988, p. 36). Keyword: Contraceptives.
• News: Report calls for openness in Medicare coverage process (MDDI, Nov 1988, p. 29). Keyword: Medicare.
• News: Proposed IOL rule meets opposition (MDDI, Nov 1988, p. 28). Keywords: Reimbursement, Intraocular Lens.
• News: Proposed postal regulation draws industry response (MDDI, Nov 1988, p. 26). Keywords: Diagnostics, Biologics, Etiological Agents.
• CFCs: going, going..., Greg Freiherr (MDDI, Oct 1988, p. 37). Keywords: Environmental Impact, CFCs.
• Washington Wrap-up: Commissionerial patronage for cholesterol test?, Larry Oster (MDDI, Oct 1988, p. 30). Keyword: Diagnostics.
• Washington Wrap-up: Mohan reports approval 'bad news', Larry Oster (MDDI, Oct 1988, p. 30). Keywords: Product Approval.
• Washington Wrap-up: IVD guidelines, Larry Oster (MDDI, Oct 1988, p. 28). Keyword: Diagnostics.
• Washington Wrap-up: GMP paper problems, Larry Oster (MDDI, Oct 1988, p. 28). Keywords: Compliance, GMPs.
• Washington Wrap-up: FDA reclassifications, Larry Oster (MDDI, Oct 1988, p. 28). Keyword: Reclassification.
• 1992 in perspective, Mika O. Reinikainen (MDDI, Oct 1988, p. 24). Keywords: Europe, EC92, European Regulations.
• News: Task groups make recommendations, David Haut (MDDI, Oct 1988, p. 20). Keyword: Software.
• News: Manufacturers take assertive role, David Haut (MDDI, Oct 1988, p. 17). Keyword: Reimbursement.
• News: Device bill passes House, David Haut (MDDI, Oct 1988, p. 16). Keyword: Legislation.
• Washington Wrap-up: Consolidating FDA, Larry Oster (MDDI, Sep 1988, p. 40). Keywords: Legislation, Organization.
• Washington Wrap-up: Laboratory bill, Larry Oster (MDDI, Sep 1988, p. 40). Keyword: Laboratories.
• Washington Wrap-up: Tampon ratings, Larry Oster (MDDI, Sep 1988, p. 38). Keywords: Ob/Gyn Devices.
• Washington Wrap-up: Reclassification woes, Larry Oster (MDDI, Sep 1988, p. 38). Keyword: Reclassification.
• Washington Wrap-up: Device legislation, Larry Oster (MDDI, Sep 1988, p. 38). Keyword: Legislation.
• News: HCFA stalls payment for hemodialyzer bloodlines, David Haut (MDDI, Sep 1988, p. 32). Keywords: Reimbursement, Blood Devices.
• News: FDA considers glove guidelines, David Haut (MDDI, Sep 1988, p. 30). Keywords: Gloves, Guidelines.
• News: Liability case troubles industry, David Haut (MDDI, Sep 1988, p. 28). Keywords: Product Liability.
• Campaign '88: interviews with the candidates' health policy advisors, David Haut (MDDI, Sep 1988, p. 18). Keywords: Political Influence, Legislation.
• Washington Wrap-up: Medicare changes, Larry Oster (MDDI, Aug 1988, p. 28). Keywords: Medicare, Legislation.
• Anatomy of an EEC Directive, Mika O. Reinikainen (MDDI, Aug 1988, p. 24). Keywords: Electronic Devices, Harmonization, European Regulations.
• News: Policy inches forward, David Haut (MDDI, Aug 1988, p. 23). Keyword: Software.
• News: Proposition 65; gray areas persist, David Haut (MDDI, Aug 1988, p. 21). Keyword: Proposition65.
• News: Design transfer: regulatory trouble ahead?, David Haut (MDDI, Aug 1988, p. 20). Keywords: Preproduction QA, Design Transfer.
• News: HCFA holds financial line, David Haut (MDDI, Aug 1988, p. 18). Keywords: Cost Containment, Reimbursement.
• Washington Wrap-up: Post-mortem on BioClinical case, Larry Oster (MDDI, Jul 1988, p. 24). Keyword: FDAEnforcement.
• Washington Wrap-up: Automatic detention of imports, Larry Oster (MDDI, Jul 1988, p. 24). Keywords: FDAEnforcement, Imports.
• Washington Wrap-up: Other CDRH accomplishments, Larry Oster (MDDI, Jul 1988, p. 22). Keywords: Management, Risk Assessment.
• News: Industry unsettled over guideline, David Haut (MDDI, Jul 1988, p. 20). Keyword: Software.
• News: Trade bill's future unclear, David Haut (MDDI, Jul 1988, p. 20). Keywords: Legislation, Exports.
• News: FDA blocks home AIDS tests, David Haut (MDDI, Jul 1988, p. 19). Keywords: AIDS, Home Testing.
• News: Proposition 65: is it spreading?, David Haut (MDDI, Jul 1988, p. 18). Keyword: Proposition65.
• News: CFC production limit: too little too late?, David Haut (MDDI, Jul 1988, p. 16). Keyword: CFCs.
• News: FDA categorizes preproduction recalls, David Haut (MDDI, Jul 1988, p. 16). Keywords: Preproduction QA, Recalls.
• Industry reps: up from second-class citizenship: an interview with Amiram Daniel, PhD, Director of Diagnostic Manufacturing and Biotechnology Programs, HIMA, David Haut (MDDI, Jul 1988, p. 14). Keywords: Advisory Panels, Government-Industry Cooperation.
• Making device regulation work, Frank E. Samuel, Jr. (MDDI, Jul 1988, p. 10). Keywords: Industry Opinion.
• Clinical Research Q&A, Maria M. Koretz (MDDI, Jun 1988, p. 150). Keywords: IRBs, Informed Consent, Clinical Investigations.
• Guilty: home-use IVDs: avoiding liability, Jonathan S. Kahan (MDDI, Jun 1988, p. 65). Keywords: Diagnostics, Product Liability.
• Washington Wrap-up: Industry innovation, Larry Oster (MDDI, Jun 1988, p. 46). Keywords: Diagnostics, Product Approval.
• Washington Wrap-up: GMP emphasis shifts, Larry Oster (MDDI, Jun 1988, p. 46). Keywords: Diagnostics, Guidelines.
• Washington Wrap-up: When government abuses, Larry Oster (MDDI, Jun 1988, p. 44). Keywords: Diagnostics, FDAEnforcement.
• News: FDA tissue regulation slow in coming, Jonathan S. Kahan (MDDI, Jun 1988, p. 34). Keywords: Transplant Tissue.
• News: Biotech trade concerns voiced, Bruce F. Mackler (MDDI, Jun 1988, p. 33). Keywords: Exports, Biotechnology.
• News: HCFA to publish Medicare coverage criteria, David Haut (MDDI, Jun 1988, p. 32). Keywords: HCFA, Medicare, Reimbursement.
• News: Caveat importer, John F. Stigi (MDDI, Jun 1988, p. 31). Keywords: Gloves, Imports.
• News: OSMA critical of new list, David Haut (MDDI, Jun 1988, p. 29). Keywords: Critical Devices.
• News: OSHA issues excursion limit, David Haut (MDDI, Jun 1988, p. 28). Keywords: Et O, Occupational Safety.
• News: Preproduction QA given high priority, David Haut (MDDI, Jun 1988, p. 28). Keywords: Preproduction QA, Quality.
• International competition: a blueprint for action, Anthony G. Aiuvalasit, Jr. (MDDI, Jun 1988, p. 24). Keywords: Exports, International Regulations.
• Rare oppportunity (A), David M. Link (MDDI, Jun 1988, p. 22). Keyword: Quality.
• News: Industry responds to Proposition 65 requirements (MDDI, May 1988, p. 47). Keyword: Proposition65.
• News: AIDS policy: will the health-care industry take the lead? (MDDI, May 1988, p. 42). Keywords: AIDS, Personnel.
• Washington Wrap-up: 'Action Plan' fruits, Larry Oster (MDDI, May 1988, p. 15). Keywords: Classification, Radiology Devices.
• News: Antimicrobial plastic devices: is commercialization imminent? (MDDI, Apr 1988, p. 92). Keywords: Technology Transfer, Commercialization.
• News: Proposition 65 warning regulations issued (MDDI, Apr 1988, p. 91). Keywords: California, Proposition65.
• Washington Wrap-up: Repercussions on Capitol Hill and beyond, Larry Oster (MDDI, Apr 1988, p. 18). Keywords: Government Criticism, District Offices.
• Washington Wrap-up: Experts disagree, Larry Oster (MDDI, Apr 1988, p. 16). Keywords: FDAEnforcement, Compliance.
• Washington Wrap-up: More about BioClinical, Larry Oster (MDDI, Apr 1988, p. 14). Keywords: FDAEnforcement, Compliance.
• News: Health Care Innovation Act lies comatose (MDDI, Mar 1988, p. 50). Keywords: Medicare, Reimbursement, Innovation.
• Determining differences between drugs and devices, John F. Stigi (MDDI, Mar 1988, p. 42). Keywords: Terminology, Classification.
• Washington Wrap-up: FDLI: a clarification, Larry Oster (MDDI, Mar 1988, p. 13). Keyword: FDLI.
• Washington Wrap-up: HIMA's ambitions for FDA, Larry Oster (MDDI, Mar 1988, p. 12). Keywords: Industry Opinion.
• Washington Wrap-up: No resting on its laurels for CDRH, Larry Oster (MDDI, Mar 1988, p. 10). Keywords: CDRH, Product Approval.
• Washington Wrap-up: Will there be a law?, Larry Oster (MDDI, Mar 1988, p. 10). Keyword: Legislation.
• Toward a quality outcome for 1988, Daniel E. Gill (MDDI, Mar 1988, p. 8). Keyword: Quality.
• News: Exporting medical devices to West Germany (MDDI, Feb 1988, p. 52). Keywords: International Affairs, Exports.
• News: ASTM panel surveying hospital reuse patterns (MDDI, Feb 1988, p. 50). Keyword: Reuse.
• News: EPA issues CFC proposal; action on EtO imminent (MDDI, Feb 1988, p. 48). Keywords: Et O, EPA, CFCs.
• Profile of IDE applications, Carl F. Blozan (MDDI, Feb 1988, p. 42). Keyword: IDEs.
• Biotechnology Dialogue: California Proposition 65 update, Bruce F. Mackler (MDDI, Feb 1988, p. 28). Keyword: Proposition65.
• Biotechnology Dialogue: United States signs free trade agreement with Canada, Bruce F. Mackler (MDDI, Feb 1988, p. 26). Keywords: International Trade.
• Washington Wrap-up: Focus on quality (A), Larry Oster (MDDI, Feb 1988, p. 16). Keyword: Quality.
• Guidelines aren't regulations (and other lessons from the federal courts), William D. Appler (MDDI, Feb 1988, p. 10). Keywords: FDAEnforcement, Guidelines.
• News: FDA seizure of explanted pacemakers stirs controversy (MDDI, Jan 1988, p. 121). Keywords: Product Seizures, Reuse, Exports.
• News: CITEHC: a boon or a bane to industry? (MDDI, Jan 1988, p. 120). Keywords: CITEHC, Standards Setting, Standards.
• News: Pending legislation offers limited help for orphan device development (MDDI, Jan 1988, p. 118). Keywords: Legislation, Orphan Devices.
• What's ahead for 1988?: thoughts on priorities and strategies for the coming year (MDDI, Jan 1988, p. 50). Keyword: Forecasts.
• Season of conferences and revelations (A), Mika O. Reinikainen (MDDI, Jan 1988, p. 24). Keywords: European Regulations, International Affairs.
• Washington Wrap-up: 'Orphan device' defined; incentives sought, Larry Oster (MDDI, Jan 1988, p. 16). Keywords: Orphan Devices.
• Washington Wrap-up: Quality-of-care reemerges as a primary goal, Larry Oster (MDDI, Jan 1988, p. 15). Keywords: Long-Term Care.
• Washington Wrap-up: Will unfettered competition be allowed to continue?, Larry Oster (MDDI, Jan 1988, p. 14). Keywords: Regulatory Climate.
• FDA's software policy: troubling implications, Edward M. Basile (MDDI, Jan 1988, p. 10). Keyword: Software.

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1987

• Washington Wrap-up: Novel use of the petition process (A), Larry Oster (MDDI, Dec 1987, p. 14). Keyword: Labeling.
• Washington Wrap-up: Software policy: deregulation lives, Larry Oster (MDDI, Dec 1987, p. 12). Keywords: Software, Deregulation.
• Washington Wrap-up: Legislation moving again?, Larry Oster (MDDI, Dec 1987, p. 12). Keyword: Legislation.
• Washington Wrap-up: No more backlogs!, Larry Oster (MDDI, Dec 1987, p. 10). Keywords: CDRH, Product Approval.
• Washington Wrap-up: CDRH accused of slowness, Larry Oster (MDDI, Nov 1987, p. 72). Keywords: Ob/Gyn Devices, Cardiovascular Devices.
• Washington Wrap-up: FDA 'politicization', Larry Oster (MDDI, Nov 1987, p. 72). Keywords: Political Influence.
• Minimizing product liability exposure in device labeling, Bruce F. Mackler (MDDI, Nov 1987, p. 28). Keywords: Product Liability, Labeling.
• Proposition 65: not a scary beast, David Roe (MDDI, Nov 1987, p. 24). Keyword: Proposition65.
• Washington Wrap-up: Cleaning out 510(k) waste, Larry Oster (MDDI, Nov 1987, p. 16). Keywords: Deregulation, 510(k)s.
• Washington Wrap-up: New FDA rules for health fraud, Larry Oster (MDDI, Nov 1987, p. 15). Keywords: Health Fraud.
• Washington Wrap-up: Are FDA's centers too secretive?, Larry Oster (MDDI, Nov 1987, p. 15). Keywords: Government Relations.
• Washington Wrap-up: Scant comfort in FOI changes, Larry Oster (MDDI, Nov 1987, p. 14). Keyword: FOI.
• Medical devices: an atypical regulatory climate?, Gerard J. Griesmer (MDDI, Nov 1987, p. 10). Keywords: Environmental Impact, Safety, Regulatory Climate.
• Washington Wrap-up: Contact lens cleaner problems, revisited, Larry Oster (MDDI, Oct 1987, p. 18). Keywords: Contact Lens.
• Washington Wrap-up: Suntanning controversy pits federal versus town law, Larry Oster (MDDI, Oct 1987, p. 18). Keyword: Sunlamp.
• Washington Wrap-up: Color-safety challenge ahead?, Larry Oster (MDDI, Oct 1987, p. 14). Keywords: Color Additives.
• Washington Wrap-up: Less advice, more speed?, Larry Oster (MDDI, Oct 1987, p. 14). Keywords: Advisory Panels, Product Approval.
• Preproduction quality assurance: no surprise, James W. Hartman (MDDI, Oct 1987, p. 10). Keywords: Preproduction QA, Design Review.
• Final PMA regulations (The): ten months later, Jonathan S. Kahan (MDDI, Sep 1987, p. 46). Keywords: Premarket Approvals, Regulations, Product Approval.
• FDA and dialyzer reuse: separating fact from fiction, Edmund G. Lowrie (MDDI, Sep 1987, p. 28). Keyword: Reuse.
• Biotechnology Dialogue: German Drug Law update, Bruce F. Mackler (MDDI, Sep 1987, p. 25). Keywords: Germany, International Affairs.
• Biotechnology Dialogue: Word processing approach to expedite PMAs revisited, Bruce F. Mackler (MDDI, Sep 1987, p. 24). Keywords: Product Approval.
• Biotechnology Dialogue: EPA proposes toxic chemical rule, Bruce F. Mackler (MDDI, Sep 1987, p. 22). Keywords: Environmental Impact, Hazardous Waste, EPA.
• Biotechnology Dialogue: FDA issues 'Points to Consider' that affects monoclonal antibody products, Bruce F. Mackler (MDDI, Sep 1987, p. 22). Keywords: Biologics, Points To Consider.
• Biotechnology Dialogue: FDA GMP inspectional guidelines found unenforceable, Bruce F. Mackler (MDDI, Sep 1987, p. 22). Keywords: Guidelines, FDAEnforcement.
• Washington Wrap-up: OMB altering one rule in four, Larry Oster (MDDI, Sep 1987, p. 21). Keywords: Political Influence.
• Washington Wrap-up: Senate considers levying annual fees on approved devices, Larry Oster (MDDI, Sep 1987, p. 21). Keywords: User Fees.
• Washington Wrap-up: CDRH to lead new risk assessment program, Larry Oster (MDDI, Sep 1987, p. 20). Keywords: Risk Assessment.
• Washington Wrap-up: Full speed ahead for new device law, Larry Oster (MDDI, Sep 1987, p. 18). Keywords: Legislation, Product Approval.
• Medical devices and regulatory letters: an analysis of FDA enforcement actions, Jeffrey N. Gibbs (MDDI, Aug 1987, p. 42). Keywords: FDAEnforcement, GMPs.
• California's Proposition 65: labeling requirements ahead?, Gary Yingling (MDDI, Aug 1987, p. 34). Keywords: Environmental Impact, Proposition65, Hazardous Waste.
• Washington Wrap-up: MDR extended, piecemeal, Larry Oster (MDDI, Aug 1987, p. 18). Keyword: MDR.
• Washington Wrap-up: Preproduction QA guide issued, Larry Oster (MDDI, Aug 1987, p. 18). Keywords: Guidelines, Quality.
• Washington Wrap-up: FDA chief a presidential appointee?, Larry Oster (MDDI, Aug 1987, p. 16). Keywords: Political Influence, Management.
• Washington Wrap-up: New device legislation inevitable, Larry Oster (MDDI, Aug 1987, p. 14). Keywords: Legislation, Regulatory Climate, Product Approval.
• Sterile packaging: what can we expect from FDA?, Joseph D. O'Brien (MDDI, Aug 1987, p. 10). Keywords: Sterilization, Testing.
• Medical product sterilization: changes and challenges, James F. Jorkasky (MDDI, Jul 1987, p. 32). Keywords: Environmental Impact, Sterilization, Safety.
• Washington Wrap-up: FOI setback (An), Larry Oster (MDDI, Jul 1987, p. 12). Keyword: FOI.
• Washington Wrap-up: Turning up the heat, Larry Oster (MDDI, Jul 1987, p. 10). Keywords: Cost Containment, Political Influence.
• Beyond FDA: coverage and payment hurdles, B. Kristine Johnson (MDDI, Jul 1987, p. 8). Keywords: DRGs, Reimbursement, Technology Assessment.
• Determining 'increased frequency' under the MDR rule, Bogdan Dziurzynski (MDDI, Jun 1987, p. 92). Keyword: MDR.
• MDR inspections: what to expect and how to prepare, Edward M. Basile (MDDI, Jun 1987, p. 84). Keywords: Compliance, MDR, Inspections.
• CDRH's Jim Benson: Making systematic improvements in the product evaluation process, James S. Benson (MDDI, Jun 1987, p. 76). Keywords: Forecasts, Product Approval, Assistance.
• High-priority devices: how are they chosen?, Harvey Rudolph (MDDI, Jun 1987, p. 64). Keywords: Problem Definition Study, Prioritization.
• Critical devices: guilty until proven innocent?, Eldon E. Frisch (MDDI, Jun 1987, p. 52). Keywords: Advisory Committees, Critical Devices.
• Biotechnology Dialogue: FDA addresses ABC convention, Bruce F. Mackler (MDDI, Jun 1987, p. 36). Keyword: Biotechnology.
• Medical device regulation in the smaller European countries, Mika O. Reinikainen (MDDI, Jun 1987, p. 28). Keywords: International Affairs, European Regulations.
• Washington Wrap-up: Easing tort concerns, Larry Oster (MDDI, Jun 1987, p. 22). Keywords: Product Liability.
• Washington Wrap-up: Welcoming user fees?, Larry Oster (MDDI, Jun 1987, p. 20). Keywords: User Fees.
• Washington Wrap-up: Upgrades for MDR analysis, Larry Oster (MDDI, Jun 1987, p. 20). Keyword: MDR.
• Device regulation: oversight, not legislative reform, Larry R. Pilot (MDDI, Jun 1987, p. 12). Keywords: Legislation, Amendments.
• Biotechnology Dialogue: Worldwide patent harmonization necessary to prevent discrimination, Bruce F. Mackler (MDDI, May 1987, p. 29). Keywords: International Affairs, Biotechnology, Patents.
• Biotechnology Dialogue: FDA developing 510(k) guidance manual, Bruce F. Mackler (MDDI, May 1987, p. 28). Keywords: Manuals, 510(k)s, Biotechnology.
• Biotechnology Dialogue: FDA considering diskette submission to expedite PMA negotiations., Bruce F. Mackler (MDDI, May 1987, p. 26). Keywords: Package Inserts, Product Approval.
• SMA News: Questions most often asked of DSMA (MDDI, May 1987, p. 22). Keywords: Amendments, Regulations, Product Approval.
• Washington Wrap-up: Investigator compensation bill, Larry Oster (MDDI, May 1987, p. 12). Keywords: Commercialization, Clinical Investigations.
• Washington Wrap-up: ECT survivors show skill, Larry Oster (MDDI, May 1987, p. 12). Keywords: Electroconvulsive Therapy, Reclassification.
• Washington Wrap-up: Inspectors with cameras, Larry Oster (MDDI, May 1987, p. 10). Keyword: Inspections.
• Washington Wrap-up: Secretarial reclassification?, Larry Oster (MDDI, May 1987, p. 10). Keyword: Reclassification.
• Reuse: once more, with emphasis, Edward R. Duffie, Jr. (MDDI, May 1987, p. 8). Keywords: Product Liability, Reuse.
• Return of the STEL (The), Timothy A. Rice (MDDI, Apr 1987, p. 24). Keywords: OSHA, Safety, Et OResiduals.
• Washington Wrap-up: Boost of deregulation around the corner? (A), Larry Oster (MDDI, Apr 1987, p. 16). Keywords: Diagnostics, Deregulation.
• Washington Wrap-up: Case in point (A), Larry Oster (MDDI, Apr 1987, p. 14). Keywords: Regulatory Climate.
• Washington Wrap-up: Changes foreseen in the regulatory climate, Larry Oster (MDDI, Apr 1987, p. 14). Keywords: Regulatory Climate.
• Validating computer systems, Jonathan S. Kahan (MDDI, Mar 1987, p. 48). Keywords: Validation, GMPs, Computer Systems.
• Are you prepared for the FDA inspection?, Martha M. Bennett (MDDI, Mar 1987, p. 30). Keyword: Inspections.
• Washington Wrap-up: Revision of IDE rules, Larry Oster (MDDI, Mar 1987, p. 24). Keywords: Commercialization, IDEs.
• High motives in technology and health care, Karl D. Bays (MDDI, Mar 1987, p. 10). Keywords: Cost Containment, Industry Opinion.
• SMA News: More case studies of device recalls (MDDI, Feb 1987, p. 53). Keyword: Recalls.
• Biotechnology Dialogue: FDA sensitivities in evaluating immunological devices, Bruce F. Mackler (MDDI, Feb 1987, p. 25). Keyword: Biotechnology.
• Biotechnology Dialogue: PMA environmental-impact considerations, Bruce F. Mackler (MDDI, Feb 1987, p. 24). Keywords: Environmental Impact, Premarket Approvals.
• Washington Wrap-up: He's a bureaucrat, too, Larry Oster (MDDI, Feb 1987, p. 18). Keyword: 510(k)s.
• Washington Wrap-up: Mohan revolution (The), Larry Oster (MDDI, Feb 1987, p. 18). Keywords: Product Approval.
• Washington Wrap-up: New FOI charges to be assessed, Larry Oster (MDDI, Feb 1987, p. 16). Keyword: FOI.
• Washington Wrap-up: Quality of care looms, Larry Oster (MDDI, Feb 1987, p. 16). Keywords: Cost Containment.
• Washington Wrap-up: Brighter outlook (A), Larry Oster (MDDI, Feb 1987, p. 14). Keywords: Political Influence, Reimbursement.
• FR Update: Federal Register citations: April-September 1986, Martin Friedman (MDDI, Jan 1987, p. 100). Keywords: Federal Register.
• HR 5516: viewpoints on the Medical Device Improvement Act of 1986, Ted R. Mannen (MDDI, Jan 1987, p. 40). Keywords: Legislation, Industry Opinion.
• Where goes Germany?, Mika O. Reinikainen (MDDI, Jan 1987, p. 28). Keywords: Germany, European Regulations.
• Washington Wrap-up: Without controversy, would FDA act?, Larry Oster (MDDI, Jan 1987, p. 20). Keywords: Ob/Gyn Devices, Government Criticism.
• Washington Wrap-up: End to FDA's regulatory-initiative recess (An), Larry Oster (MDDI, Jan 1987, p. 18). Keywords: Legislation, Regulatory Climate.
• HR 5516: much-needed reform, Henry A. Waxman (MDDI, Jan 1987, p. 12). Keywords: Legislation, Product Approval.

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1986

• Washington Wrap-up: 510(k) FOI crisis fades (The), Larry Oster (MDDI, Dec 1986, p. 23). Keyword: FOI.
• Washington Wrap-up: New improvements unwelcome, Larry Oster (MDDI, Dec 1986, p. 18). Keywords: Legislation, Industry Opinion.
• Washington Wrap-up: PMA regulations: a spirit of cooperation, Larry Oster (MDDI, Dec 1986, p. 16). Keywords: Premarket Approvals, Government-Industry Cooperation.
• GMPAC: a perspective, Thomas