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Medical Device & Diagnostic Industry Articles  
 
2001
Listening to Industry: Ombudsman Les Weinstein Comments on His Role in CDRH (MDDI)
CDRH Ombudsman Weinstein details the responsibilities and initiatives of his position, and shares industry dispute and complaint statistics for the year 2000.
Shifting the Device Risk Burden (MDDI)
Does a recent device approval indicate a softening of FDA's "appropriate use" worries?
An FDA Veteran's Toughest Device Approval (MDDI)
Final labeling includes more indications than originally requested.
FDA and the Temptations of Expanded Authority (MDDI)
Proposed rule establishes procedures that the agency will follow to rescind 510(k) clearance decisions.
Establishment Registration: Keeping Pace with an Evolving Industry (MDDI)
Increases in outsourcing and corporate acquisitions make establishment registration issues relevant to all manufacturers—not just start-ups. With changes to the current regulations pending, manufacturers need to understand their responsibilities.
Preparing for an FDA Advisory Committee Meeting (MDDI)
A clear, informative presentation can alleviate agency concerns about a product and introduce it favorably to the public.
An Unceremonious Exit: Does Henney Leave a Newly Politicized FDA? (MDDI)
Although the device industry and its advocacy groups have been largely silent, there is no lack of rhetoric as FDA awaits the next commissioner.
When FDA Doesn't Want Preemption (MDDI)
A fraud-based case has elicited a new FDA position on preemption.
FDA Guidance on Review Procedures Made Available (MDDI)
FDA explains methods for identifying and responding to deficiencies.
Agenda for the Century: Henney Pledges Good Science, Openness at FDA (MDDI)
Addressing the National Press Club on a politically historic day, FDA Commissioner Jane Henney outlines the agency's fundamental operating principles for the years ahead.
 
2000
Your Device Promo on FDA's Web Site? (MDDI)
In an effort to persuade medical device companies to convert to its new paperless registration system, the agency is considering offering firms free promotional space on its Web site.
HCFA Under Fire: Frustrations Focus on Reimbursement (MDDI)
Even as relations between the device industry and FDA continue to improve, the Medicare monolith engenders ever-greater conflict and acrimony.
An Echo of FDA Wrongdoing? (MDDI)
Another device reclassification leads to controversy involving the CDRH division overseeing dental devices.
New FDA Review Chief Brings Industry Background (MDDI)
With experience in academia, hospital administration, and industry consulting, new director of device evaluation Bernard Statland vows to keep his focus on patients.
Justify Device Reuse Curbs on Your Labels, FDA Says (MDDI)
A committee hearing over single-use device reuse establishes new agency priorities but provides little relief for OEMs.
FDA's Plan for Web-Based Device Labeling (MDDI)
CDRH's goals for its home page enhancements include posting simple, clearly written device labeling on its site.
FDA Proposes Easier Device Tracking Rule (MDDI)
FDAMA provision relaxes and clarifies manufacturers' device tracking obligations.
HIMA, FDA Converge on Third-Party Reviews (MDDI)
FDA was once opposed to outside reviews of product submissions. Now industry is scrambling to catch up with the agency's aggressive plans to support the concept.
Finally, FDA Moves Broadly on Device Reprocessors (MDDI)
A draft guidance document issued in February details the agency's new across-the-board enforcement scheme for reprocessed devices.
Shaping initiatives that lead to Stronger Healthcare (MDDI)
Working to implement a public policy that supports HIMA's strategic plan, the organization's president, Pamela Bailey, is looking to medical manufacturers for help in meeting her objectives.
FDA to Industry: Keep Your Own Secrets (MDDI)
In a cost-cutting move, FDA makes manufacturers responsible for ensuring the confidentiality of premarket notification applications.
On Reprocessors and Research, FDA Gently Yields (MDDI)
Two recent actions show FDA's readiness to accommodate industry concerns.
FDA Going "Direct" to Companies (MDDI)
CDRH set to introduce a new electronic communications link that it claims will facilitate contact with industry.
 
1999
After Abbott, A Tougher FDA Is Emerging (MDDI)
Does the record-setting Abbott consent decree signal a more stringent FDA enforcement policy? At a minimum, the agency is showing how seriously it will view quality system violations and the promises made to correct them.
A Scholarly Article You Can't Promote (MDDI)
Despite recent court findings against its position, FDA continues to contest the dissemination of unapproved-use information.
Novel Devices Won't Suffer, but the Others? (MDDI)
According to CDRH director Feigal, prioritization by FDA will affect review times.
New FDA Devices Chief Feigal: A Positive First Impression (MDDI)
CDRH director sees most problems between industry and the agency rooted in poor communication, vows to work closely with industry.
What's The Frequency?: FCC & FDA Ponder Telemetry Transmissions (MDDI)
In another example of issues raised by the expanding technological base of medical devices, the advent of digital TV is crowding the airwaves.
Third-Party Device Reviews Beat FDA's (MDDI)
Private-sector reviews of 510(k) submissions average 33% faster than those conducted by the agency.
FDA Action Plan to Improve Regulation of Biologic Devices (MDDI)
CBER will harmonize its policies with CDRH.
Device User Fees: More Needed than Ever, Just as Unpopular (MDDI)
FDA's budgetary problems are garnering little sympathy with device manufacturers, who remain unmoved by renewed calls for user fees.
From FDA Quality System Regulation to CE Marking (MDDI)
Awareness of the similarities and differences between U.S. and EU regulatory systems can help manufacturers satisfy both regimens and meet CE marking requirements.
Understanding FDA's Electronic Records and Signatures Regulation (MDDI)
The implementation of FDA's 1997 rule raises legal and regulatory issues for device companies.
File Closes on Document Leak: Final investigation leaves key questions unresolved (MDDI)
The thought of FDA giving highly sensitive documents about your product to your competitor before you go to market is about the worst nightmare a medical device maker could have. It's also a serious criminal matter.
FDA/Industry Partnerships: Moving toward More Equitable Enforcement (MDDI)
Reversing what was often an adversarial relationship, FDA has worked with representatives of the device industry to implement changes designed to improve the agency's inspection and enforcement policies.
Casting an Interactive Web: Henney Seeks Real-Time Input from Industry (MDDI)
Will new media help implement FDAMA's mandate for engagement and interaction between FDA and device companies? A recent event tests a powerful mechanism for dialogue.
Careful Study Marks Henney's First Months (MDDI)
The new FDA commissioner plays it close to the vest while expressing a willingness to work with the industry.
Lightening the Regulatory Burden (MDDI)
Defining "least-burdensome" concept is turning out to be quite a burden.
FDA Finalizes Off-Label Dissemination Rule (MDDI)
The agency's codification of requirements for companies communicating unapproved-use information reflects stringent interpretation of FDAMA.
Device and Biologic Combination Products: Understanding the Evolving Regulation (MDDI)
FDA is establishing new policies and guidelines to deal with combination device and biologic products. Manufacturers must keep abreast of the latest developments to avoid costly delays.
Section 207: Is Your Class III Designation Really Final? (MDDI)
Also known as "de novo," section 207 of FDAMA allows certain low-risk medical devices to be reclassified into Class I or Class II, thereby avoiding costly PMAs.
Year-End Report Notes Faster Reviews, More Changes at FDA (MDDI)
CDRH gives itself high marks for fiscal year 1998 accomplishments.
FDAMA: One Year Later: An anniversary review of the legislation (MDDI)
A year after the FDA Modernization Act was signed into law, a top HIMA official assesses the benefits of the new provisions and raises ongoing concerns regarding future implementation.
The Voice From The Top: Henney's "Recall" Signals A New Era at FDA (MDDI)
Jane Henney begins her term as the new FDA commissioner by restating her commitment to ongoing agency reforms.
 
1998
FDA Promotes Shorter PMA Summaries, Faster Inspections (MDDI)
Simplifying requirements appears to be a current theme at the agency.
Henney Delivers Positive Message to Device Makers (MDDI)
The nominee's response to detailed questioning by a Senate committee reveals an openness and willingness to cooperate with industry.
Quid Pro Quo: FDA Pilot Program Needs Industry Support (MDDI)
In an effort to make FDA inspections more efficient, the agency is examining several different plans, including the Hazard Analysis of Critical Control Points (HACCP). An increasing number of manufacturers have expressed an interest in HACCP lately, but only Cyberonics (Houston) has gone ahead and implemented it as part of FDA's pilot program.
How Will Medical Devices Fare in Henney's FDA? (MDDI)
The new nominee for FDA commissioner has plenty of experience in Washington but a rocky track record with the device industry.
Making Her World Work: The Nominee For FDA Commissioner (MDDI)
An interview with Jane E. Henney, MD, vice president of the University of New Mexico Health Sciences Center and nominee for FDA commissioner.
FDA Emphasizes CEO Accountability (MDDI)
A recent Mentor Corp. consent decree draws in corporate subsidiaries and personnel.
FDA's New Financial Disclosure Rule: An Unnecessary New Burden (MDDI)
A partner at Hyman, Phelps & McNamara, a firm specializing in FDA law, discusses how the agency went too far in requiring financial disclosure forms in device marketing applications.
THE YEAR 2000: FDA's Absolute Last Word (for the moment . . .) (MDDI)
Issues of liability and cost allocation add more rings to the Y2K circus.
Does FDA Need Its Strong-Arm Enforcers? (MDDI)
The aftermath of an FDA raid calls the Office of Criminal Investigations' procedures into question.
Implementation of the FDA Modernization Act of 1997 (MDDI)
New FDA guidance documents provide insights into how device manufacturers will benefit from the new statute.
Industry Seeks to Stop FDA Budget Cuts (MDDI)
HIMA asks the House Appropriations Committee to stabilize FDA funding from one year to the next.
FDA Faces the Budget Ax (MDDI)
Budget cuts mean FDA must devise new strategies for medical device inspection and enforcement.
FDA's Newest Guidance Document: When the Label Doesn't Fit (MDDI)
FDA is asking manufacturers to changelabel contentto include individualization of treatment and patient counseling.
The FDA Modernization Act of 1997: Part I (MDDI)
The device industry's efforts to reform FDA have resulted in a far-reaching new law, which is detailed in this series.
Tighter FDA Budget May Mean Fewer, Shorter Inspections (MDDI)
Agency statistics indicate that FDA will refocus its enforcement activities in 1998.
FDA Reforms Are Rolling, so It's Time to Focus on Going Global (MDDI)
HIMA's chairman-elect suggests new issues the industry should tackle following the enactment of the FDA Modernization Act.
Will 1998 Be the Year of Reimbursement? (MDDI)
To realize the full potential of the FDA reforms, manufacturers now need to smooth the reimbursement process as well.
Device Industry Wins Big in FDA Reform (MDDI)
The FDA Modernization Act of 1997 makes many changes to the agency requested by the medical device industry.
Lessons Learned, New Challenges: Life after FDA Reform (MDDI)
MDMA's former executive director examines the medical device industry's history, recent legislative victories, and the challenges it faces.
A Troubled Affair (MDDI)
FDA fails to apologize for mishandling Myo-tronics device evaluations.
The FDA Modernization Act: Staying a New Course (MDDI)
In addition to improving patient access to needed medical device technologies, the new act may also trigger some changes within the industry.
 
1997
Rare Harmony Marks FDA Reform Bills on Hill (MDDI)
Industry and FDA work together to draft wording of House bill.
The New FDA Regulation on Reports of Corrections and Removals (MDDI)
Regulation ties the risk-to-health standard to existing Class I and II definitions.
FDA Invites Industry to Accept a Faster Alternative to PMAs (MDDI)
To speed product approvals, FDA is reviving an inactive statute that gets the agency involved early during product development.
Addressing FDA's Concerns about Electromagnetic Interference (MDDI)
Along with the great strides in medical electronics in recent years come concerns on the part of medical device manufacturers and FDA about electromagnetic interference (EMI) with devices.
In Its Bold New Course, FDA Needs Industry's Help (MDDI)
Anticipating budget cuts, CDRH dodges the question of device user fees but suggests streamlined procedural changes, third-party reviewers.
FDA Guidance on 510(k) Submissions (MDDI)
FDA's recently issued guidance provides the agency and industry a common ground for determining when to submit a new 510(k) for changes to an existing device. The agency recognizes that manufacturers make many changes to their devices each year and often question whether to submit new 510(k)s.
The Progress and Potential of FDA Inspections (MDDI)
If FDA wants to promote rather than stifle innovation, it must continue to modify its inspection procedures. In the past, an FDA inspection of a manufacturer's facility was often an adversarial encounter: FDA's goal was to collect evidence for prosecution or another type of regulatory action. But in the mid-1990s, reduced congressional funding forced the agency to reevaluate its operation.
A 'New Way of Life' at FDA (MDDI)
Center for Devices and Radiological Health director Bruce Burlington reveals new strategies for reforming the agency from within.
After Kessler, What Kind of FDA? (MDDI)
The resignation of FDA's most controversial leader in years presents FDA reformers and the medical device industry with a new challenge.
FDA Makes Quality the Rule (MDDI)
FDA's final revision of the medical device GMP regulation brings U.S. manufacturing into line with international quality systems standards.
Another Bloody Season in the FDA-Congress Wars? (MDDI)
The departure of David A. Kessler as FDA commissioner is being seen as cause for optimism in the medical device industry. Not much consideration has yet been given to the possibility that the selection process for Kessler's successor could be the precursor to a season of FDA-congressional warfare.
 
1996
FDA Reform Legislation Does a Slow Fade (MDDI)
FDA reform legislation began dying as Congress adjourned for its August recess, but that doesn't mean that the old FDA will come back on the rampage, bigger and meaner than ever, as some reform advocates have warned. The truth is, that old dragon had already been fading, partly of its own accord and partly out of budget-borne necessity.
FDA's New MDR Regulations: What Manufacturers Need to Know (MDDI)
On July 31, 1996, the new medical device reporting (MDR) regulations for medical device manufacturers and user facilities became effective—at least for the most part. The long-awaited regulations, which were published in the Federal Register on December 11, 1995, implement adverse event reporting provisions of the Safe Medical Devices Act of 1990 (SMDA) and amend existing reporting requirements for manufacturers as required by the Medical Device Amendments of 1992. FDA's distributor reporting regulations are unaffected by the new regulations.
New-Age FDA Brings Many Reforms (MDDI)
Combined with pilot testing of external product reviews by FDA's Center for Devices and Radiological Health, the earnest changes under discussion in the grassroots meetings add up to a new age for FDA and its relationship with industry.
Leadership and Reform: FDA's Ongoing Duty (MDDI)
Virtually everyone, it seems, is in favor of FDA reform. Such sentiments are not new--even within the agency--but the demands being voiced now are qualitatively different from those of the past. To begin with, they are louder, and they are coming simultaneously from many sectors of society. More important, today's demands are aimed at modifying some of the agency's fundamental operating principles.
FDA and the Cost of Health Care (MDDI)
As the Clinton administration and Congress grapple with finding ways to reduce the cost of health care, both have overlooked FDA, the one government agency that causes health-care costs to continually rise.
Legislating a New and Improved FDA (MDDI)
Two months ago, more than 300 individuals and patient groups signed an "open letter" to Congress. They made an astounding statement, one that was powerful in its simplicity: FDA delays are killing people. Consumer protection means more than just keeping unsafe and ineffective products off the market. It is at least as important that safe and effective products are made available to people who need them as quickly and as efficiently as possible.
FDA Regulatory Programs: Cooperation and Common Sense Typify a Record of Success (MDDI)

For a good portion of the past 20 years, FDA worked in partnership with industry to ensure that safe and effective devices proceeded expeditiously to market while unsafe and ineffective devices were the subject of agency enforcement action. Unfortunately, the 1990s--a period some have derisively termed the "Kessler era of regulation"--have been extremely detrimental to the growth and profitability of the medical device industry. Many small companies simply could not survive the slowdown in device clearances and the additional layers of regulation imposed by FDA under Commissioner David Kessler. Only now, after years of regulatory dysfunction, is FDA entering a more rational and moderate era of device regulation, partly because of pressure from Congress and industry.
The Demise of Rule Making and the Rise of Guidances (MDDI)
With authority from Congress, FDA makes and enforces law. But over the past two decades, the process of regulating the medical device industry has changed profoundly.
The Changing Role of Education in FDA's Regualtion of Medical Devices (MDDI)
FDA has for years struggled with the merits of voluntary compliance and education as complements to its traditional regulatory role.
The Evolution of Biomaterials Liability (MDDI)
On March 11, 1996, James S. Benson visited the White House to encourage President Clinton to sign legislation that would protect the makers of biomaterials from liability. In those discussions, Benson was a representative of the medical device industry, but he brought to bear experience gained in a number of top-level positions at FDA and at the Health Industry Manufacturers Association. Benson has sought for years to put liability issues surrounding biomaterials into perspective. In this interview with MD&DI, Benson discusses the evolution of those issues over the last 20 years.
The Making of a Regulatory Profession (MDDI)
In 1972, the executive management of my company assigned me the task of forming a corporate regulatory affairs department. The goals I adopted as part of this task were as lofty as they could be, and ranged from ensuring that all company departments consistently complied with regulatory requirements to promoting the company as one that satisfied both the letter and the spirit of those requirements.
Heroic Efforts to Save FDA Reform (MDDI)
Mid-March was the last chance for the medical device and biotechnology industries to steer FDA reform legislation in their favor and realistically expect passage this year.
Partnership Efforts Take Roots-Up Approach (MDDI)
Judging from a number of developments at both the national and regional levels, FDA appears to be undergoing a veritable transformation--a shift in culture that is bringing many in the agency to view device manufacturers as partners rather than as adversaries.
Reporting Rule Serves as a Test of Agency Reform (MDDI)
A major FDA final rule on medical device manufacturer reporting procedures has become an unintended test of the agency's readiness to reform itself internally in the face of congressional efforts to inflict reform externally.
Burlington to HIMA: A Challenge, or a Threat? (MDDI)
Relationships between FDA and the medical device industry are not supposed to be cozy. Even when the two are cooperating, their interests should never fully align. Indeed, it's a mark of a healthy regulatory relationship when each side regularly challenges the other without rancor or fear of retribution.
FDA's Small Business Representatives: Lending a Helping Hand to Small Device Firms (MDDI)
The FDA good manufacturing practices (GMP) inspection process can be something of a mystery even to well-established medical device companies. Start-up companies have even less knowledge of what the agency focuses on during its inspections and may stumble badly during a preapproval or routine GMP inspection. Fortunately, the agency has a program to help all types of FDA-regulated industries achieve voluntary compliance with the laws and regulations it enforces.
FDA to Form Committee on Design Control Inspections (MDDI)
Inspectional strategies for design control will be the focus of an ad hoc industry committee to be appointed by FDA later this year (1996), according to Kimberly Trautman, acting director of the Cardiovascular/Neurology Branch in the Office of Compliance at the agency's Center for Devices and Radiological Health.
FDA Urges Company Policy on Web Use (MDDI)
FDA is monitoring the Internet. At present there is no unifying agency policy on this activity, nor is there any formal or concerted effort across the various centers to routinely monitor what company employees say electronically.
FDA Withdraws Laerdal Warning Letter (MDDI)
Do you remember FDA ever officially withdrawing a warning letter or its equivalent? Medical device attorney Larry Pilot of the law firm McKenna & Cuneo (Washington, DC), says he cannot--which makes a letter he recently received unique.
Breakthrough at FDA (MDDI)
Through its grassroots regulatory partnership meetings held around the country, FDA seems to have successfully broken loose from the policy noose that is the Washington Beltway and opened a constructive dialogue with the medical device industry.