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Medical Devices
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Documents
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
- Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data. (Issued September 25, 2006)
- Guidance for Industry and Food and Drug Administration Staff: Compliance With the Medical Device User Fee and Modernization Act of 2002, as amended--Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (Issued May 1, 2006)
- 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 - Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices (Issued September 25, 2006)
- Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended - Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (Issued May 1, 2006)
- 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) NOTE: This guidance document is outdated and has been removed from CDRH's web site. An archived copy may be obtained from CDRH's Division of Small Manufacturers, International, and Consumer Assistance (DSMICA), please contact dsmica@cdrh.fda.gov. Devices previously covered by this document that are eligible for 510(k) third party review will retain "non-pilot" status pending CDRH's issuance of updated guidance. Additional information about the third party review program is available at http://www.fda.gov/cdrh/thirdparty/.
- 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: Enforcement of FDA Requirements on 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
- Reuse of Single Use Devices - Standards
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