GAO Reports
Guidances
Letters
Standards

Articles

Article in User Facility Reporting Bulletin: Selecting a Third-Party Reprocessor for Single-Use Devices (10/07/2002)

Article in User Facility Reporting Bulletin: "Extensions Granted to Enforcement Priorities for Reprocessed Single-Use Devices" (06/25/2002)

Article in User Facility Reporting Bulletin: "Changes in Enforcement of FDA's Requirements on Reprocessing of Single-Use Devices" (06/25/2002)

Article in User Facility Reporting Bulletin: "FDA sends another Letter to Hospitals About Reuse of Single-Use Devices" (06/25/2002)

Article in User Facility Reporting Bulletin: "Using Standards in Premarket Submissions for Reprocessed Single-Use Devices" (06/25/2002)

Article in User Facility Reporting Bulletin: "FDA is Seeking Comments and Suggestions on Labeling Reprocessed Single-Use Devices" (06/25/2002)

Article in User Facility Reporting Bulletin: "Changes in Enforcement Deadline for Reprocessed Class II Single -Use Devices"(06/25/2002)

Article in User Facility Reporting Bulletin: "Effects of Repeated Ethylene Oxide Sterilization on Synthetic Absorbable Sutures" (06/25/2002)

Article: "Reusing Disposable Medical Devices." North American Precis Syndicate, Inc. (NAPS) was used to distribute this article which was sent to over 10,000 newspapers throughout the country (06/25/2002)

Article in User Facility Reporting Bulletin: "PMA Submissions Now Due for Reprocessed Class III Single-Use Devices" (3/2001)

The 34th issue of the User Facility Reporting Bulletin, a 10-page issue, is devoted entirely to the reprocessing and reuse of single-use device (SUDs) by hospitals. The premarket and non-premarket regulatory requirements are covered in short overviews of the topics with extensive websites given for obtaining more detailed information from the many FDA/CDRH guidance documents and searchable databases. (07/13/2001)

FDA Consumer Magazine Article: "Reusing Medical Devices: Ensuring Safety the Second Time Around" (9-10/2000) - August 18, 2000

Article in User Facility Reporting Bulletin: "FDA Releases Final Guidance on the Reprocessing and Reuse of Single-Use Devices" (8/2000)

Article in User Facility Reporting Bulletin: "Reuse of Single Use Devices" (12/1999)

Congressional Testimonies

Statement of Daniel Schultz, M.D., Director CDRH, Before the Committee on Government Reform - September 26, 2006

Statement by Dr. David W. Feigal before the Senate to discuss the Agency's approach to the issue of reuse of medical devices labeled for single-use - June 27, 2000

Statement by Dr. David W. Feigal, Director CDRH,  Before the Subcommittee on Oversight and Investigations-February 10, 2000

Executive Summaries

Executive Summary for Open Meeting: FDA's Proposed Strategy on Reuse of Single-Use Devices, December 14, 1999

Survey on the Reuse and Reprocessing of Single-Use Devices (SUDs) in U.S. Hospitals - Executive Summary, October 16, 2002

FDA Talk Papers

FDA Talk Paper: FDA Actions on Reprocessed Single Use Devices (issued 8/17/01)

Talk Paper: FDA Issues Final Guidance on Reuse of Single-Use Medical Devices - August 2, 2000

Federal Register Notices

Single-Use Devices; Termination of Exemptions from Premarket Notification; Requirement for Submission of Validation Data (issued 9/29/2005)

Medical Devices; Semicritical Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data (issued 4/13/2004)

FDA announces avalability of revised Medwatch Form to facilitate the reporting of adverse events involving single-use devices (SUDs) (issued 2/17/2004)

Announcement of Office of Management and Budget Approval; Submission of Validation Data for Reprocessed Single-Use Devices (issued 8/28/2003)

Agency Emergency Processing Under OMB Review; submission of Validation Data for Reprocessed Single-Use Devices; Correction (issued 8/20/2003)

Agency Emergency Processing Under OMB Review; Submission of Validation Data for Reprocessed Single-Use Devices; Correction (issued 7/23/2003)

Agency Emergency Processing Under OMB Review; Submission of Validation Data for Reprocessed Single-Use Devices (issued 7/8/2003)

Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data (issued 6/26/2003)

Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data (issued 4/30/2003)

FDA requests comments in Federal Register Notice: Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices; Request for Comments and Information (issued 8/28/02)
Note that the correct docket number is 02n-0456.

FDA requests comments and information in Federal Register Notice. Medical Devices; Guidance on Labeling of Reprocessed Single Use Devices; Request for Comments and Information (issued 12/20/01)

GAO Reports

GAO Report: Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted (6/20/2000) - August 18, 2000

Guidances

CDRH encourages the use of device specific guidances, if available. Please visit our publicly searchable guidance database to search for a complete list and newly available guidances.

Guidance for Industry and FDA Staff: Frequently Asked Questions (FAQs) on the Status of Reprocessed Single Use Devices (SUDs) that receive a Not Substantially Equivalent (NSE) Letter, November 8, 2004

Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices; Guidance for Industry and FDA Staff (posted June 1, 2004)

Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Three Additional Questions; Guidance for Industry, FDA Staff, Third-Party and Hospital Reprocesors, July 16, 2003 (posted August 7, 2003)

Medical Device User Fee and Modernization act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Rprocessed Single-Use Medical Devices (posted July 8, 2003)

Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices - Guidance for Industry and FDA Staff (posted 7/3/2003)

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 9, 2002

Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA (issued November 16, 2001)

Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals; Final Guidance for Industry and FDA (issued 7/30/2001)

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 - Dated 7/6/01

Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff  (6/1/01)

Guidance on Adverse Event Reporting for Hospitals that Reprocess Devices Intended by the Original Equipment Manufacturer for Single Use - Dated April 24, 2001 

Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals - August 14, 2000

Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme (Draft)- February 8, 2000

Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996

FDA Proposed Strategy on Reuse of Single-Use Devices - Updated November 1, 1999

Compliance Policy (CPG 7124.16) Section 300.500 Reuse of Medical Disposable Devices - September 24, 1987

Letters

Letter to Hospitals Re: Changes in Enforcement of FDA's Requirements on Reprocessing of Single-Use Devices (Issued September 25, 2001)

Letter Requesting Hospitals to Volunteer for FDA Site Visits as Part of a Pilot Program - Dated April 20, 2001, Expires May 25, 2001  

Letter to Hospitals Re: Reprocessing of Single Use Devices - April 23, 2001 

Letter to Hospitals Re: Reprocessing of Single-Use Devices - September 28, 2000

Letter Re: Commercial Reprocessors of Disposable Medical Devices - Dated July 13, 1998

Letter Re: Policies That May Apply to The Reuse of Single-Use or Disposable Medical Devices - Dated December 27, 1995

Standards