Resources
Federal Register:
Medical Device Reporting - January 11, 2006
Federal Register: Draft Guidance for Industry and Food and
Drug Administration Staff; Procedures for Handling Post-Approval Studies
Imposed by Premarket Approval Application Order; Availability.
- September 16. 2005
Federal
Register: Guidance-Accredited Third Parties; Requests for Inspection by an
Accredited Person Under the Inspections by Accredited Persons Program
Authorized by the Medical Device User Fee and Modernization Act of 2002;
Availability - September 16.
2005
Procedures for Handling Post-Approval Studies Imposed by PMA Order - Draft
Guidance for Industry and FDA Staff
- September 16. 2005
Requests for
Inspection by an Accredited Person Under the Inspection by Accredited
Persons Program Authorized by Section 201 of the Medical Device User Fee and
Modernization Act of 2002 Guidance for Industry, FDA Staff, and
FDA-Accredited Third-Parties - September 16. 2005
FY 2006 MDUFMA
Small Business Qualification Worksheet and Certification - Guidance for
Industry and FDA - August
18, 2005
Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and
FDA Staff - August 17, 2005
Federal
Register: MEDICAL Device user Fee Rates for Fiscal Year 2006
- August 12, 2005
FDA/CDRH
Annual Report Fiscal Year 2004
- July 6, 2005
The Food and Drug
Law Institute / CDRH Report on Meeting to Discuss Unique Device
Identification - April 14-15, 2005
- June 22, 2005
Federal
Register: Medical Devices; Medical Device Reporting; Confirmation of
Effective Date - June 17, 2005
Guidance for the Content of Premarket Submissions for Software Contained in
Medical Devices - Guidance for Industry and FDA Staff
- May 13, 2005
Center for Devices and
Radiological Health - Organizational Structure - Updated
- April 7, 2005
Federal
Register: Food and Drug Administration/Drug Information Association Cross
Labeling; Public Meeting; Combination Products and Mutually Conforming
Labeling. - March 31, 2005
Medical Devices;
Medical Device Reporting; Companion to Direct Final Rule
- March 1, 2005
Medical Devices;
Medical Device Reporting -
March 1, 2005
Report to
Congress: Barriers to the Availability of Medical Devices Intended for the
Treatment or Diagnosis of Diseases and Conditions that Affect Children
- January 25, 2005
Presentation: Best Practices for Effective and Productive Premarket
Meetings with CDRH.
- January 19, 2005
CDRH/CBER
MDUFMA Stakeholder Meeting Agenda - November 18, 2004
Stimulating
Innovation in Medical Technologies, Public Meeting -
October 15, 2004
Guidance for Third Parties and FDA Staff; Third Party Review of Premarket
Notifications - October 7, 2004
Federal
Register: Second Annual Stakeholder Meeting on the Implementation of the
Medical Device User Fee and Modernization Act of 2002 Provisions; Public
Meeting - November 18, 2004 - September 30, 2004
August
2004 GAO Report - FDA's Progress Toward Achieving MDUFMA's Performance Goals
Information on
Pediatric Medical Devices - Sept. 14, 2004
Daniel G.
Schultz, M.D., Named Director of FDA's Center for Devices
and Radiological Health -
July 23, 2004
Federal
Register: Civil Money Penalties Hearings; Maximum Penalty Amounts and
Compliance With the Federal Civil Penalties Inflation Adjustment Act
- July 23, 2004
Presentation: Medical Device User Fee and Modernization act of 2002
(MDUFMA) - Quarterly Update - July 15, 2004
A
Pilot Program to Evaluate a Proposed Globally Harmonized
Alternative for Premarket - July 8, 2004
Federal
Register: Possible Barriers to the Availability of Medical Devices
Intended to Treat or Diagnose Diseases and Conditions that Affect
Children; Request for Comments - June 22, 2004
FDA
Critical Path Initiative - The Critical Path to New Medical Products -
June 22, 2004
Announcement of
2nd Annual MDUFMA Stakeholder Meeting to be held
Thursday, November 18, 2004 - Posted June 18, 2004
Presentation:
MDUFMA Second Quarter FY 04 Report - June 8, 2004
Draft
Guidance for Industry, Food and Drug Administration Staff, and
Food and Drug Administration-Accredited Third-Parties: Requests for
Inspection by an Accredited Person Under the Inspections by Accredited
Persons Program Authorized by Section 201 of the Medical Device User
Fee and Modernization Act of 2002 - June 2, 2004
FDA
Talk Paper - FDA Revises Guidance on Reprocessing of Single-Use
Devices - Revisions Clarify FDA's Review Procedures - June 2, 2004
Notification
Submissions (510(k)s) - June 1, 2004
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 -
June 1, 2004
Premarket
Assessment of Pediatric Medical Devices - Guidance for Industry and FDA
Staff - May 14, 2004
Federal
Register: Draft Guidance for Industry on Combination Products,
Timeliness of Premarket Reviews, Dispute Resolution; Availability -
May 5, 2004
Draft Guidance
for Industry: Combination Products, Timeliness of
Premarket Reviews: Dispute Resolution Guidance - May 5, 2004
Strategic Planning:
Process Improvement Accomplishments - April 30, 2004
MDUFMA
First Quarter FY 04 Report - April 4, 2004
FDA
News: Report Seeks to Improve 'Critical Path' of Medical Product
Development - March 17, 2004
Announcement
of Public Workshop: "Quality Systems Educational Forum:
Production and Process Controls.'' This public workshop is
intended to
provide information about FDA's Medical Device Quality Systems
Regulation (QSR) to the regulated industry, particularly small
businesses.
"Help-Seeking"
and Other Disease Awareness Communications by or on
Behalf of Drug and Device Firms - Draft Guidance for Industry
- February 5, 2004
Consumer-Directed
Broadcast Advertising of Restricted Devices -
Draft Guidance for Industry
and FDA -
February 5, 2004
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
Bundling
Multiple Devices or Multiple Indications in a Single Submission
- Guidance for Industry and FDA Staff - November 21, 2003
Premarket
Approval Application Modular Review - Guidance for Industry and
FDA Staff - October 31, 2003
Third
Party Inspections and the Accredited Persons Inspection Program
- October 24, 2003
Annual
Stakeholder Meeting on the Implementation of the Medical Device
User Fee and Modernization Act of 2002 (MDUFMA) - December
3, 2003
Part
11, Electronic Records; Electronic Signatures - Scope and
Application - Guidance for Industry (Multi-Center Guidance)
- Sept. 5, 2003
Explanation
of New Goal for Reducing Device Approval Times - Aug. 27,
2003
Premarket
Assessment of Pediatric Medical Devices - Draft Guidance for
Industry and FDA Staff - July 23, 2003
Protecting
the Public Health: FDA Pursues an Aggressive Enforcement
Strategy - July 1, 2003
Medical
Devices: A Pilot Program to Evaluate a Proposed Globally
harmonized Alternative to Premarket Procedures; Final Guidance
for Industry and FDA Staff; Availability - June 26, 2003
Medical
Devices; Reprocessed Single-Use Devices; Termination of
Exemptions from Premarket Notification; Requirements for
Submission of Validation Data - June 26, 2003
Compliance
with Section 301 of the Medical Device User Fee and
Modernization Act of 2002 - Identification of Manufacturer of
Medical
Devices - Draft Guidance for Industry and FDA Staff - June
19, 2003
Actions
and Reports with a Due Date Specified by the Medical Device User
Fee and Modernization Act of 2002 or by Regulations and Notices
Issued to Implement MDUFMA - updated June 3, 2003
FY 2003
MDUFMA Fee Payment Instructions - May 15, 2003
CDRH
Contacts for specific Billing Issues Related to
Medical Device User Fees - May 13, 2003
Guidance
Documents:
Medical Device Tracking - Guidance for Industry and FDA Staff
- May 1, 2003
Premarket
Approval Application Filing Review - Guidance for Industry and
FDA Staff - 5/2/03
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 - April 24, 2003
Financial
relationships and interests in research involving human
subjects; protection guidance. NOTES: (1) Guidance document is
included in the ® 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
Annual
Guidance Agenda - April 3, 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 - Feb. 25, 2003
Medical
Device User Fee Payment Procedures - Feb. 25, 2003
Related
Document: Part 11, Electronic Records; Electronic Signatures - Scope and
Application - Feb. 25, 2003
Assessing
User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy
Supplement Definitions, Bundling Multiple Devices in a Single Application,
and Fees for Combination Products; Guidance for Industry and FDA -
Feb. 24, 2003
Guidance for
Industry and FDA: FY 2003 MDUFMA Small Business Qualification Worksheet
and Certification - Feb. 24, 2003
Medical
Device Warning Letter Pilot Termination - Feb. 11, 2003
FDA
Launches Initiative to Improve Development, Availability of Innovative
Medical Products - Jan. 31, 2003
Related
Document: Executive Summary - Jan. 31, 2003
Related
Document: Full Report - Improving Innovation in Medical Technology:Beyond
2002 - Jan. 31, 2003
Medical
Devices; Exemptions From Premarket Notification; Class II Devices -
Jan. 31, 2003
Guidance for
Industry; Collection of Race and Ethnicity Data in Clinical Trials -
Jan. 23, 2003
Office of Device
Evaluation (ODE) Fiscal Year 2002 Annual Report - Jan. 7, 2003
"The FDA Approval and Medicare Coverage Processes, Part 2 Striving
toward Harmonization" - to request a copy email you name and address
to IMDMC by clicking here.
- Dec. 30, 2002
MDUFMA
- Clarification to 510(k) Fees for FY 2003 - Dec. 23, 2002
Determination
of Intended Use for 510(k) Devices; Guidance for CDRH Staff - December
12, 2002
Performance Goals
For The Medical Device User Fee And Modernization Act Of 2002 --
(Senate - November 19, 2002)
Establishment
of Medical Device User Fee Rates for Fiscal Year 2003 and Interim
Procedures - November 18, 2002
Actions and
Reports with a Due Date Specified by the Medical Device User Fee and
Modernization Act of 2002 - November 14, 2002
Draft
Guidance for Industry on Electronic Records; Electronic Signatures,
Electronic Copies of Electronic Records - Nov. 12, 2002
Information on the
Medical Device User Fee and Modernization Act (MDUFMA) of 2002 - Nov.
5, 2002
Device Advice:
Premarket Approval (PMA) - Nov. 1, 2002
CDRH Home Health
Care Committee - Nov. 5, 2002
FDA
Regulation of Combination Products; Public Hearing - October 28, 2002
HHS
Welcomes Passage of Device User Fee Legislation - News Release - Oct.
21, 2002
Agency
Information Collection Activities: Submission for OMB Review; Comment
Request; FDA Rapid Response Surveys - Oct. 17, 2002
Survey on
the Reuse and Reprocessing of Single-Use Devices (SUDs) in U.S. Hospitals
- Executive Summary - Oct. 17, 2002
Blue Book Memo -
Intercenter Consultative/Collaborative Review Process (G02-1) - Oct.
4, 2002
Industry Portal
Debuts on FDA Website - Oct. 1, 2002
Least
Burdensome Provision of the FDA Modernization Act of 1997: Concept and
Principles: Final Guidance for FDA and Industry - Oct. 1, 2002
Draft Guidance for
Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered
Plants for Use in Humans and Animals - Sept. 13
CDRH Establishes New
Office to Regulate In Vitro Diagnostic Devices - Sept. 16
Draft
Guidance for Industry, Electronic Records; Electronic Signatures,
Maintenance of Electronic Records; Availability - Sept. 6, 2002
Updated 510(k)
Sterility Review Guidance K90-1; Guidance for Industry and FDA - Sept.
6
Medical
Device Use in the Home Health Care Community; Public Meeting - August
21, 2002
Guidance for
Industry: FDA Export Certificates - August 13, 2002
Frequently Asked
Questions on the Recognition of Consensus Standards; Guidance for
Industry and for Industry and FDA Staff - July 31, 2002
Frequently-Asked-Questions
about the Reprocessing and Reuse of Single-Use Devices by Third-Party and
Hospital Reprocessors: Three Additional Questions; Final Guidance
for Industry and FDA Staff - July 15, 2002
PDF Enabled Version
of Form FDA 2892 - Device Listing for Medical Device Establishments - Now
Available Again - 6/20/02
Protection
of Human Subjects in Clinical Trials; Public Meeting - 6/20/02
Postmarket
Surveillance - June 6, 2002
Office
of Health and Industry Programs (OHIP) Fiscal Year 2001 Annual Report -
June 6, 2002
FDA
Steps Up Surveillance of Medical Devices To Prevent Unforeseen Problems,
Better Protect Patients - June 6, 2002
Medical
Device Public Workshop - May 28, 2002
Exports;
Notification and Recordkeeping Requirements; Stay of Effective Date -
May 14, 2002
Letter: Important
Information on Medical Devices - May 16, 2002
Real Time Review for In Vitro Diagnostic Supplements - May 9, 2002
De Novo Classification for In Vitro Diagnostic
Devices - May 9, 2002
CDRH
Ombudsman Annual Report for 2001 - May 8, 2002
CDRH Organization Chart
- Updated - May 3, 2002
Presentation:
FDA's CLIA Complexity Process - April 30, 2002
Bioresearch
Monitoring (BIMO) Initiatives - April 5, 2002
Third
Annual Report of the Medical Devices Annex to the U.S./EC
Mutual Recognition Agreement (MRA) - April 2, 2002
CDRH
Contacts Listing - April 2, 2002
Draft
Guidance for Industry on Electronic Records; Electronic Signatures, Time
Stamps - March 22, 2002
FDA
Office of Orphan Products Development FY2001 Accomplishments - March
19, 2002
FDA
Performance Plan FY2002 - Medical Devices and Radiological Health -
March 11, 2002
IMDMC
Comments submitted to the Federal Advisory Committee on Regulatory Reform -
March 5, 2002
Letter
from DSMICA: Important Information on Medical Devices - Updated February
2002 - March 4, 2002
Blue
Book Memo: Fax & E-Mail Communication with Industry about Premarket
Files Under Review 3/01/02 (A02-01)- March 4, 2002
U.S.
Agent for Devices - Sample Notification Letter - March 4, 2002
ODE
Annual Report for FY 2001 - March 4, 2002
Change in
Enforcement Deadline Associated with Reprocessing of Class II Single-Use
Devices - February 18, 2002
FDA
Proposes New Guidance for Financial Disclosure by Advisory Committee
Members - February 18, 2002
A Vision for Medicare Reform: Better
Healthcare for Patients, Better Economy for Healthcare, IMDMC -
February 12, 2002
FDA Patient Safety News for
Health Care Personnel - February 7, 2002
Draft
Guidance: Disclosure of Conflicts of Interest for Special Government
Employees Participating in FDA Product Specific Advisory Committees -
Feb. 4, 2002
HDE Checklist for
Filing Decision - Updated - Jan. 30, 2002
Related
Document: Required Elements for a Declaration of Conformity to a
Recognized Standard - Jan. 30, 2002
Screening
Checklist for All Premarket Notification [510(k)] Submissions - Updated
- Jan. 30, 2002
Medical
Devices; Availability of Safety and Effectiveness Summaries for Pre-market
Approval Applications (Jan. 23, 2002)
Hematology
and Pathology Devices; Reclassification of the Automated Differential Cell
Counter (Jan. 23, 2002)
FDA
Modernization Act of 1997: Modifications to the List of Recognized
Standards, Recognition List Number: 006 (Jan. 23, 2002)
Agency
Information Collection Activities; Submission for OMB Review; Comment
Request; Medical Devices; Third-Party Premarket Submission Review and
Quality System Inspections Under United States/European Community Mutual
Recognition Agreement (Jan. 23, 2002)
Medical
Devices: General Principles of Software Validation, Final Guidance
for Industry and FDA Staff Availability. (Jan. 23, 2002)
Sterilized
Convenience Kits for Clinical and surgical Use; Final Guidance for
Industry (Jan. 23, 2002)
Exports:
Notification and Recordkeeping Requirements (Jan. 7, 2002)
Minutes
from the Thirteenth US/EC MRA Medical Device Annex Stakeholders
Teleconference (November 7, 2001)
Draft
Guidance for Clinical Trial Sponsors on the Establishment and Operation of
Clinical Trial Data Monitoring Committees 11/26/01
Science
at Work in CDRH: A Report on the Role of Science in the Regulatory
Process" from the CDRH
Reuse of Single
Use Devices: FDA's Regulatory Requirements for Third Party and Hospital
Reprocessors
Guidance for
FDA Staff - The Leveraging Handbook
Draft FDA
Guidance on the Establishment and Operation of Clinical Trial Data
Monitoring Committees; Public Meeting
Medical Device
Recalls
Procedures
for Handling Inquiries Regarding the Need for an Investigational Device
Exemptions Application for Research Involving Medical Devices
CDRH,
Office of Device Evaluation Annual Report, FY 2000
Resolving Scientific Disputes Concerning the Regulation of Medical
Devices; A Guide to Use of the Medical Devices Dispute Resolution Panel;
Final Guidance for Industry and FDA
List of Over-the
Counter In Vitro Diagnostic Devices which have been cleared for
marketing by FDA's Division of Clinical Laboratory Devices. Released by
the CDRH.
"'Operation Cure.All' Wages New Battle in
Ongoing War Against Internet Health Fund" (6-14-01article from
the CDRH website)
Summaries for
510(k)s Final Decisions Rendered for May 2001 from the CDRH
Guidance Document: "Frequently
Asked Questions about the Reprocessing and Reuse of Single Use Devices by
Third Party and Hospital Reprocessors; Final Guidance for Industry and FDA
Staff"
FDA Letter to
Hospitals regarding the reprocessing of single use devices. Dated
4/23/01.
"Guidance
for Industry and FDA Staff -- Reduction of Civil Money Penalties for Small
Entities."
Guidance Document: "Implementation
of the Biomaterials Access Assurance Act of 1998; Draft Guidance for
Industry and FDA."
