| Advisory
Committees; Tentative Schedule of Meetings for 2004 |
December 30, 2003
|
| Memorandum
of Understanding Between the Food and Drug Administration, Department of
Health and Human Services of the United States of America and Swissmedic
of the Swiss Confederation Regarding Exchange of Information About
Pharmaceutical Products for Human and Animal Use and Medical Devices |
December 30, 2003
|
| Memorandum
of Understanding Between the Food and Drug Administration and the Health
Products and Food Branch, Health Canada of Canada Regarding Sharing and
Exchange of Information about Therapeutic Products |
December 30, 2003
|
| Advisory
Committees; Filing of Annual Reports |
December 23, 2003
|
| Guidance
for Industry and FDA Staff; Premarket Notification Submissions for
Chemical Indicators; Availability |
December 19, 2003
|
| Class
II Special Controls Guidance Document: Human Dura Mater; Guidance for
Industry and FDA; Availability |
December 18, 2003
|
| Neurological
Devices; Classification of Human Dura Mater |
December 18, 2003
|
| Advisory
Committee Information Hotline |
December 18, 2003
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Premarket Notification Submissions. |
December 16, 2003
|
| Agency
Information Collection Activities; Announcement of the Office of
Management and Budget Approval; Inspection by Accredited Persons Program
Under the Medical Device User Fee and Modernization Act of 2002 |
December 9, 2003
|
| Amending
the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to
Race and Ethnicity |
December 8, 2003
|
| Guidance
for Industry and FDA Staff; Class II Special Controls Guidance Document:
Dental Sonography and Jaw Tracking Devices; Availability. |
December 2, 2003
|
| Draft
Guidance for Industry and Food and Drug Administration Staff; Premarket
Submissions and Labeling Recommendations for Drugs of Abuse Screening
Tests; Availability |
December 2, 2003
|
| Medical
Devices: Classification of the Dental Sonography Device and Jaw Tracking
Device |
December 2, 2003
|
| Dental
Devices; Gold Based Alloys, Precious Metal Alloys, and Base Metal Alloys;
Designation of Special Controls |
December 2, 2003
|
| Draft
Guidance for Industry and FDA Staff; Class II Special Controls Guidance
Document: Dental Precious Metal Alloys and Class II Special Controls
Guidance Document: Dental Base Metal Alloys; Availability |
December 2, 2003
|
| Civil
Money Penalties Hearings; Maximum Penalty Amounts and Compliance With the
Federal Civil Penalties Inflation Adjustment Act |
December 2, 2003
|
| Agency
Information Collection Activities; Announcement of OMB Approval 0910-0264;
Export of Medical Devices--Foreign Letters of Approval |
December 2, 2003
|
| Agency
Information Collection Activities; Announcement of OMB Approval 0910-0131;
Agreement for Shipment of Devices for Sterilization |
December 2, 2003
|
| Premarket
Submission and Labeling Recommendations for Drugs of Abuse Screening Tests
- Draft Guidance for Industry and FDA Staff |
December 2, 2003
|
| Medical
Devices; Guidance for Industry and FDA Staff; Bundling Multiple Devices or
Multiple Indications in a Single Submission; Availability |
November 26, 2003
|
| Guidance
for Industry and FDA Staff: Expedited Review of Premarket Submissions for
Devices; Availability |
November 26, 2003
|
| Guidance
for Industry and Food and Drug Administration Staff; User Fees and Refunds
for Premarket Approval Applications; Availability |
November 24, 2003
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Focus Groups as Used by the Food and Drug Administration |
November 24, 2003
|
| Orthopaedic
and Rehabilitation Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting |
November 21, 2003
|
| Agency
Information Collection Activities; Announcement of Office of Management
and Budget Approval; Electronic Records; Electronic Signatures |
November 21, 2003
|
| Expedited
Review of Premarket Submissions for Devices - Guidance for Industry and
FDA Staff |
November 21, 2003
|
| User
Fees and Refunds for Premarket Approval Applications - Guidance for
Industry and FDA Staff |
November 21, 2003
|
| Medical
Devices; Effective Date of Requirement for Premarket Approval for Three
Class III Preamendments Devices. |
November 18, 2003
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Mammography Facilities, Standards, and Lay Summaries for Patients |
November 7, 2003
|
| List
of Accredited Persons; Inspection by Accredited Persons Program Under the
Medical Device User Fee and Modernization Act of 2002. |
November 6, 2003
|
| Medical
Devices; Availability of Safety and Effectiveness Summaries for Premarket
Approval Applications |
November 6, 2003
|
| Guidance
for Industry and Food and Drug Administration Staff; Premarket Approval
Application Modular Review; Availability |
November 3, 2003
|
| Guidance
for Industry and FDA Staff; Class II Special Controls Guidance Document:
Endotoxin Assay; Availability |
October 31, 2003
|
| Medical
Devices; Immunology and Microbiology Devices; Classification of the
Endotoxin Assay |
October 31, 2003
|
| Circulatory
System Devices Panel of the Medical Devices Advisory Committee; Notice of
Meeting |
October 30, 2003
|
| Medical
Devices; Immunology and Microbiology Devices; Classification of the West
Nile Virus lgM Capture Elisa Assay |
October 30, 2003
|
| Guidance
for Industry and FDA Staff: Class II Special Controls Guidance Document:
West Nile Virus Seriological Assay; Availability |
October 30, 2003
|
| Draft
Guidance for Industry and FDA Staff; Use of Symbols on Labels and in
Labeling of In Vitro Diagnostic Devices Intended for Professional
Use;Availability |
October 28, 2003
|
| Guidance
for Industry and FDA Staff on Class II Special Controls Guidance Document:
Arrhythmia Detector and Alarm; Availability |
October 28, 2003
|
| Medical
Devices; Reclassification of Automated External Defibrillators |
October 28, 2003
|
| Medical
Devices; Availability of Safety and Effectiveness Summaries for Premarket
Approval Applications |
October 28, 2003
|
| FDA
Modernization Act of 1997: Modifications to the List of Recognized
Standards, Recognition List Number: 008; Correction |
October 28, 2003
|
| Medical
Devices: Cardiovascular Devices: Reclassification of the Arrhythmia
Detector and Alarm |
October 28, 2003
|
| General
and Plastic Surgery Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting |
October 24, 2003
|
| Agency
Information Collection Activities; Submission for Office of Management and
Budget Review; Comment Request; Medical Device User Fee and Modernization
Act Small Business Qualification Certification (Form FDA 3602). |
October 10, 2003
|
| Agency
Information Collection Activities; Announcement of Office of Management
and Budget Approval; The FDA Medical Products Reporting Program |
October 10, 2003
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Prevention of Medical Gas Mix-ups at Health Care Facilities |
October 10, 2003
|
| Guidance
for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval
Applications: Effect on FDA Review Clock and Performance Assessment;
Availability |
October 8, 2003
|
| Agency
Information Collection Activities; Submission for Office of Management and
Budget Review; Comment Request; Inspection by Accredited Persons Program
Under the Medical Device User Fee and Modernization Act of 2002 |
October 8, 2003
|
| Agency
Information Collection Activities; Submission for Office of Management and
Budget Review; Comment Request; Reporting and Recordkeeping Requirements
and Availability of Sample Electronic Products for Manufacturers and
Distributors of Electronic Products |
October 7, 2003
|
| Annual
Stakeholder Meeting on the Implementation of the Medical Device User Fee
Modernization Act of 2002 Provisions; Public Meeting |
September 29, 2003
|
| Circulatory
System Devices Panel of the Medical Devices Advisory Committee; Notice of
Meeting |
September 15, 2003
|
| Agency
Information Collection Activities; Submission for Office of Management and
Budget Review; Comment Request; Product Jurisdiction Assignment of Agency
Component for Review of Premarket Applications |
September 15, 2003
|
| Agency
Information Collection Activities; Announcement of Office of Management
and Budget Approval; Administrative Detention and Banned Medical Devices |
September 10, 2003
|
| Technical
Electronic Product Radiation Safety Standards Committee; Notice of
Meeting. |
September 10, 2003
|
| Agency
Information Collection Activities; Announcement of Office of Management
and Budget Approval; Investigational Device Exemptions Reports and Records |
September 9, 2003
|
| Ophthalmic
Devices Panel of the Medical Devices Advisory Committee; Notice of
Meeting. |
September 9, 2003
|
| Guidance
for Industry on Part 11, Electronic Records; Electronic Signatures--Scope
and Application; Availability |
September 5, 2003
|
| General
and Plastic Surgery Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting |
September 5, 2003
|
| Medical
Devices: Mammography Quality Standards Act of 1992 and Subsequent
Mammography Quality Standards Reauthorization Act and Amendments;
Inspection Fees |
September 4, 2003
|
| Agency
Collection Information Activities; Submission for Office of Management and
Budget Review; Comment Request; Importer's Entry Notice |
August 28, 2003
|
| Agency
Collection Information Activities; Announcement of Office of Management
and Budget Approval; Submission of Validation Data for Reprocessed
Single-Use Devices |
August 28, 2003
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment
Request; Export of Medical Devices--Foreign Letters of Approval |
August 26, 2003
|
| Agency
Information Collection Activities; Announcement of OMB Approval; Medical
Device User Fee Cover Sheet; Form FDA 3601 |
August 26, 2003
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment
Request; Postmarket Surveillance of Medical Devices |
August 20, 2003
|
| Agency
Emergency Processing Under OMB Review; submission of Validation Data for
Reprocessed Single-Use Devices; Correction |
August 20, 2003
|
| Guidance
for Industry and FDA Staff on the Mammography Quality Standards Act Final
Regulations Modifications and Additions to Policy Guidance Help System #6
Availability |
August 19, 2003
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment
Request; Agreement for Shipment of Devices for Sterilization. |
August 12, 2003
|
| Medical
Devices; Guidance for Industry and FDA Staff; Implantable Middle Ear
Hearing Device; Availability |
August 1, 2003
|
| Establishment
of Medical Device User Fee (MDUFMA) Rates for Fiscal Year 2004. |
August 1, 2003
|
| FY
2004 MDUFMA Small Business Qualification Worksheet and Certification -
Guidance for Industry and FDA |
August 1, 2003
|
| Patient
Safety News - August Edition - Now Available |
August 1, 2003
|
| FDA
Form 3602 - FY2004 MDUFMA Small Business Qualification Certification |
August 1, 2003
|
| MDUFMA
Fee Payment Instructions - Updated |
August 1, 2003
|
| Medical
Devices Dispute Resolution Panel of the Medical Devices Advisory
Committee; Cancellation |
July 30, 2003
|
| Guidance
for Industry and FDA Staff; Class II Special Controls Guidance Document:
Breast Lesion Documentation System; Availability. |
July 28, 2003
|
| Medical
Devices; Obstetrical and Gynecological Devices; Classification of the
Breast Lesion Documentation System. |
July 28, 2003
|
| Agency
Information Collection Activities; Announcement of OMB Approval; FDA
Safety Alert/Public Health Advisory Readership Survey |
July 28, 2003
|
| Draft
Guidance for Industry and FDA Staff; Premarket Assessment of Pediatric
Medical Devices; Availability |
July 24, 2003
|
| Guidance
for Industry and FDA Staff; Medical Device User Fee and Modernization Act
of 2002, Validation Data in Premarket Notification Submissions [510(k)s]
for Reprocessed Single-Use Medical Devices; Availability; Correction |
July 23, 2003
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment
Request; Electronic Records; Electronic Signatures |
July 23, 2003
|
| Neurological
Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
July 23, 2003
|
| Medical
Devices Dispute Resolution Panel of the Medical Devices Advisory
Committee; Notice of Meeting |
July 21, 2003
|
| Note:
After publication of this meeting in the Federal Register, this meeting
was cancelled; Please see: |
July 21, 2003
|
| Agency
Information Collection Activities: Proposed Collection; Comment Request;
MDUFMA Small Business Qualification Certification (Form FDA 3602). |
July 18, 2003
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Inspection by Accredited Persons Program Under the Medical Device User Fee
and Modernization Act of 2002. |
July 9, 2003
|
| Guidance
for Industry and FDA Staff ; Medical Device User Fee and Modernization Act
of 2002, Validation Data in Premarket Notification Submissions [510 (k)s]
for Reprocessed Single-Use Medical Devices; Availability. |
July 8, 2003
|
| Agency
Emergency Processing Under OMB Review; Submission of Validation Data for
Reprocessed Single-Use Devices. |
July 8, 2003
|
| Guidance
for Industry and FDA Staff on Class II Special Controls Guidance Document;
Breath Nitric Oxide Test System; Availability. |
July 7, 2003
|
| Medical
Devices; Clinical Chemistry and Clinical Toxicology Devices;
Classification of the Breath Nitric Oxide Test System. |
July 7, 2003
|
| Agency
Information Collection Activities: Proposed Collection; Comment Request;
User Fee Cover Sheet; Form FDA 3397 |
July 3, 2003
|
| General
and Plastic Surgery Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting |
June 26, 2003
|
| Medical
Devices; Reprocessed Single-Use Devices; Termination of Exemptions From
Premarket Notification; Requirement for Submission of Validation Data |
June 26, 2003
|
| Agency
Information Collection Activities; Announcement of OMB Approval;
Inspection by Accredited Persons Program Under the Medical Device User Fee
and Modernization Act of 2002 |
June 26, 2003
|
| Medical
Devices: A Pilot Program to Evaluate a Proposed Globally harmonized
Alternative for Premarket Procedures; Final Guidance for
Industry and FDA Staff; Availability |
June 26, 2003
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment
Request; Administrative Detention and Banned Medical Devices |
June 25, 2003
|
| Severe
Acute Respiratory Syndrome Diagnostics: Scientific and Regulatory
Challenges Public Workshop; Request for Comments (July 14, 2003) |
June 25, 2003
|
| Draft
Guidance for Industry and FDA Staff; Compliance With Section 301 of the
Medical Device User Fee and Modernization Act of 2002--Identification of
Manufacturer of Medical Devices; Availability |
June 23, 2003
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Product Jurisdiction; Assignment of Agency Component for Review of
Premarket Applications |
June 23, 2003
|
| Posting
Warning Letter Responses on FDA's Web Site; Notice of Pilot Program |
June 23, 2003
|
| Assignment
of Agency Component for Review of Premarket Applications |
June 23, 2003
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment
Request; Investigational Device Exemptions Reports and Records |
June 16, 2003
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Reporting and Recordkeeping Requirements and Availability of Sample
Electronic Products for Manufacturers and Distributors of Electronic
Products |
June 12, 2003
|
| Innovative
Systems for Delivery of Drugs and Biologics: Scientific, Clinical, and
Regulatory Challenges Public Workshop |
June 5, 2003
|
| Request
for Nominations for Nonvoting Representatives of Industry Interests on
Public Advisory Panels or Committees |
June 5, 2003
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Assessment of Public Perceptions and Knowledge of Clinical Trials and
Informed Consent Human Subject Protection |
June 5, 2003
|
| Request
for Nominations for Voting Members on Public Advisory Panels or Committees |
June 5, 2003
|
| Class
II Special Controls Guidance Document: Surgical Sutures; Guidance for
Industry and FDA; Availability |
June 3, 2003
|
| Guidance
for Industry and FDA on Pediatric Expertise for Advisory Panels;
Availability |
June 3, 2003
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Export of Medical Devices- -Foreign Letters of Approval |
June 3, 2003
|
| Orthopedic
Devices; Classification for the Resorbable Calcium Salt Bone Void Filler
Device |
June 2, 2003
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment
Request; Medical Device User Fee Cover 0x Sheet; Form FDA 3601 |
May 21, 2003
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Agreement for Shipment of Devices for Sterilization |
May 21, 2003
|
| Obstetrics
and Gynecology Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting (June 9, 2003) |
May 20, 2003
|
| Agency
Information Collection Activities; Announcement of OMB Approval; Emergency
Medical Device Shortage Program Survey |
May 15, 2003
|
| Medical
Devices: Draft Guidance for Industry and FDA; Surgical Masks--Premarket
Notification Submissions; Availability. |
May 15, 2003
|
| Dental
Amalgam; Request for Information |
May 9, 2003
|
| Medical
Devices; Reprocessed Single-Use Devices; Termination of Exemptions From
Premarket Notification; Requirement for Submission of Validation Data |
April 30, 2003
|
| Specification
for Annotated Electrocardiographic Waveform Data in Electronic Format;
Request for Comments |
April 29, 2003
|
| Implementation
of the Inspection by Accredited Persons Program Under the Medical Device
User Fee and Modernization Act of 2002; Accreditation Criteria: Guidance
for Industry, FDA Staff, and Third Parties; Availability |
April 28, 2003
|
| Federal
Register: Agency Information Collection Activities; Announcement of OMB
Approval; Fiscal Year 2003 MDUFMA Small Business Qualification
Certification (Form FDA 3602) |
April 28, 2003
|
| Federal
Register: Emergency Processing Under OMB Review; Inspection by Accredited
Persons Program Under MDUFMA |
April 28, 2003
|
| Federal
Register: FDA Modernization Act of 1997: Modifications to the List of
Recognized Standards, Recognition List Number: 008 |
April 28, 2003
|
| Federal
Register: Dental Products Panel of the Medical Devices Advisory Committee;
Notice of Meeting ID No 3955 |
April 28, 2003
|
| Circulatory
System Devices Panel of the Medical Devices Advisory Committee; Notice of
Meeting |
April 23, 2003
|
| Guidance
for Industry and FDA; Class II Special Controls Guidance Document: Optical
Impression Systems for Computer Assisted Design and Manufacturing
(CAD/CAM) of Dental Restorations; Guidance for Industry and FDA;
Availability. |
April 22, 2003
|
| Medical
Devices; Exemption From Premarket Notification; Class II Devices; Optical
Impression Systems for Computer Assisted Design and Manufacturing. |
April 22, 2003
|
| Medical
Devices: Draft Guidance for Industry and FDA Reviewers; Multiplex Tests
for Heritable DNA Markers, Mutations, and Expression Patterns;
Availability |
April 21, 2003
|
| Agency
Information Collection Activities; Announcement of OMB Approval; Medical
Device Reporting: Manufacturer Reporting, Importer Reporting, User
Facility Reporting, and Distributor Reporting. |
April 21, 2003
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment
Request; Application for Exemption From Federal Preemption of State and
Local Medical Device Requirements |
April 17, 2003
|
| Ophthalmic
Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
ID No. 3953 |
April 17, 2003
|
| Determination
of Regulatory Review Period for Purposes of Patent Extension; HYPERION LTK
SYSTEM |
April 17, 2003
|
| Annual
Guidance Agenda |
April 4, 2003
|
| Medical
Devices; Patient Examination and Surgeons' Gloves; Test Procedures and
Acceptance Criteria |
March 31, 2003
|
| Financial
relationships and interests in research involving human subjects;
protection guidance. NOTES: (1) Guidance document is included in the FR
notice, and (2) Although displaying on an FDA web site and carrying an FDA
Docket Number, this is a publication of the DEPARTMENT OF HEALTH AND HUMAN
SERVICES |
March 31, 2003
|
| Summary
Information for NeedleZap(tm) - P010065 |
March 26, 2003
|
| Summary
Information for Express(tm) and Express2(tm) Monorail and Over-the Wire
Coronary Stent Systems - P020009 |
March 26, 2003
|
| Consumer
Information on Ceramic TRANSCEND® Hip Articulation System |
March 26, 2003
|
| Medical
Devices; Reclassification of the Knee Joint Patellofemorotibial
Metal/Polymer Porous-Coated Uncemented Prosthesis and the Knee Joint
Femorotibial (Uni-compartmental) Metal/Polymer Porous-Coated Uncemented
Prosthesis |
March 24, 2003
|
| General
and Plastic Surgery Devices; Classification of Silicone Sheeting |
March 20, 2003
|
| National
Mammography Quality Assurance Advisory Committee; Notice of Meeting -
4/28/03 |
March 18, 2003
|
| Advisory
Committee; Renewals |
March 18, 2003
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment
Request; Emergency Medical Device Shortage Program Survey |
March 17, 2003
|
| Agency
Information Collection Activities: Proposed Collection; Comment Request;
Administrative Detention and Banned Medical Devices |
March 17, 2003
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Investigational Device Exemptions Reports and Records. |
March 14, 2003
|
| Medical
Devices: Draft Guidance for Industry and FDA Reviewers; Statistical
Guidance on Reporting Results From Studies Evaluating Diagnostic Tests;
Availability |
March 14, 2003
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Medical Device User Fee Cover Sheet; Form FDA 3601 |
February 26, 2003
|
| Draft
Guidance for Industry on Part 11, Electronic Records, Electronic
Signatures--Scope and Application; Availability of Draft Guidance and
Withdrawal of Draft Part 11 Guidance Documents and a Compliance Policy
Guide. |
February 25, 2003
|
| Circulatory
System Devices Panel of the Medical Devices Advisory Committee; Notice of
Meeting |
February 19, 2003
|
| Medical
Devices: Draft Guidance for Industry and FDA; The Mammography Quality
Standards Act Final Regulations Modifications and Additions to Policy
Guidance Help System #6; Availability |
February 19, 2003
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
FDA Safety Alert/Public Health Advisory Readership Survey (from 2/18/03) |
February 19, 2003
|
| Medical
Devices; Export Certificates; FDA Export Reform and Enhancement Act of
1996; Certification Fees. |
February 11, 2003
|
| Agency
Information Collection Activities; Proposed Collection; MedWatch: The FDA
Medical Products Reporting Program; Comment Request |
February 10, 2003
|
| Advisory
Committees; Tentative Schedule of Meetings for 2003; Amendment of Notice,
SUMMARY: Changes to the list of tentatively scheduled advisory committee
meetings for 2003 |
February 7, 2003
|
| Medical
Devices: Class II Special Controls Guidance Document: Antimicrobial
Susceptibility Test Systems; Guidance for Industry and FDA; Availability. |
February 5, 2003
|
| Medical
Devices; Reclassification and Codification of Fully Automated Short-Term
Incubation Cycle Antimicrobial Susceptibility Devices from Class III to
Class II. |
February 5, 2003
|
| Medical
Devices; Final Guidance on Quality System Information for Certain
Premarket Application Reviews; Availability. |
February 3, 2003
|
| Advisory
Committees; Filing of Annual Reports |
January 31, 2003
|
| Medical
Devices; Exemptions From Premarket Notification; Class II Devices |
January 30, 2003
|
| Medical
Devices; Chemical Indicators Premarket Notification [510(k)] Submissions;
Draft Guidance Industry and FDA; Availability. |
January 27, 2003
|
| Related
Document: Supporting Statement |
January 23, 2003
|
| Agency
Information Collection Activities; Announcement of OMB Approval;
Postmarket Surveillance. |
January 23, 2003
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Application for Exemption From Federal Preemption of State and Local
Medical Device Requirements. |
January 23, 2003
|
| Establishment
of Medical Device User Fee Rates for Fiscal Year 2003 and Interim
Procedures; Correction. |
January 22, 2003
|
| Final
Rule; Human Cells, Tissues, and Cellular and Tissue-Based Products;
Establishment Registration and Listing. Changes effective date. |
January 21, 2003
|
| Related
Document: Supporting Statement |
January 21, 2003
|
| Agency
Information Collection Activities; Announcement of OMB Approval;
Reclassification Petitions for Medical Devices |
January 21, 2003
|
| Medical
Devices; Availability of Safety and Effectiveness Summaries for Premarket
Approval Applications |
January 13, 2003
|
| Establishment
of Medical Device User Fee Rates for Fiscal Year 2003 and Interim
Procedures; Correction |
January 13, 2003
|
|
|
