Articles |
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Article in User Facility Reporting Bulletin: Selecting a
Third-Party Reprocessor for Single-Use Devices (10/07/2002) |
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Article in User Facility Reporting Bulletin: "Extensions
Granted to Enforcement Priorities for Reprocessed Single-Use Devices" (06/25/2002) |
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Article in User Facility Reporting Bulletin: "Changes
in Enforcement of FDA's Requirements on Reprocessing of Single-Use Devices" (06/25/2002) |
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Article in User Facility Reporting Bulletin: "FDA sends
another Letter to Hospitals About Reuse of Single-Use Devices" (06/25/2002) |
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Article in User Facility Reporting Bulletin: "Using Standards
in Premarket Submissions for Reprocessed Single-Use Devices" (06/25/2002) |
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Article in User Facility Reporting Bulletin: "FDA is Seeking
Comments and Suggestions on Labeling Reprocessed Single-Use Devices" (06/25/2002) |
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Article in User Facility Reporting Bulletin: "Changes
in Enforcement Deadline for Reprocessed Class II Single -Use Devices"(06/25/2002) |
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Article in User Facility Reporting Bulletin: "Effects
of Repeated Ethylene Oxide Sterilization on Synthetic Absorbable Sutures" (06/25/2002) |
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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) |
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Article in User Facility Reporting Bulletin: "PMA Submissions
Now Due for Reprocessed Class III Single-Use Devices" (3/2001) |
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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) |
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FDA Consumer Magazine Article: "Reusing Medical Devices: Ensuring
Safety the Second Time Around" (9-10/2000) - August 18, 2000 |
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Article in User Facility Reporting Bulletin: "FDA Releases Final
Guidance on the Reprocessing and Reuse of Single-Use Devices" (8/2000) |
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Article in User Facility Reporting Bulletin: "Reuse of Single
Use Devices" (12/1999)
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Congressional Testimonies |
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Statement of Daniel Schultz, M.D., Director CDRH, Before the Committee on Government Reform - September 26, 2006 |
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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 |
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Statement by Dr. David W. Feigal, Director CDRH, Before the Subcommittee on Oversight and Investigations-February 10, 2000 |
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Executive Summaries |
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Executive Summary for Open Meeting: FDA's Proposed Strategy on Reuse
of Single-Use Devices, December 14, 1999 |
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Survey on the Reuse and Reprocessing of Single-Use Devices (SUDs)
in U.S. Hospitals - Executive Summary, October 16, 2002
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FDA Talk Papers |
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FDA Talk Paper: FDA Actions on Reprocessed Single Use Devices (issued
8/17/01) |
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Talk Paper: FDA Issues Final Guidance on Reuse of Single-Use Medical
Devices - August 2, 2000
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Federal Register Notices |
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Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data. (Issued September 25, 2006) |
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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) |
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Single-Use Devices; Termination of Exemptions from Premarket Notification;
Requirement for Submission of Validation Data (issued 9/29/2005) |
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Medical Devices; Semicritical Reprocessed Single-Use Devices; Termination
of Exemptions From Premarket Notification; Requirement for Submission
of Validation Data (issued 4/13/2004) |
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FDA announces avalability of revised Medwatch Form to facilitate the
reporting of adverse events involving single-use devices (SUDs) (issued
2/17/2004) |
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Announcement of Office of Management and Budget Approval; Submission
of Validation Data for Reprocessed Single-Use Devices (issued 8/28/2003) |
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Agency Emergency Processing Under OMB Review; submission of Validation
Data for Reprocessed Single-Use Devices; Correction (issued 8/20/2003) |
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Agency Emergency Processing Under OMB Review; Submission of Validation
Data for Reprocessed Single-Use Devices; Correction (issued 7/23/2003) |
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Agency Emergency Processing Under OMB Review; Submission of Validation
Data for Reprocessed Single-Use Devices (issued 7/8/2003) |
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Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions
From Premarket Notification; Requirement for Submission of Validation
Data (issued 6/26/2003) |
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Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions
From Premarket Notification; Requirement for Submission of Validation
Data (issued 4/30/2003) |
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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. |
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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)
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GAO Reports |
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GAO Report: Single-Use Medical Devices: Little Available Evidence
of Harm From Reuse, but Oversight Warranted (6/20/2000) - August 18,
2000
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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.
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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)
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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)
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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 |
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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) |
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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) |
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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) |
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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) |
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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 |
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Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for
Industry and FDA (issued November 16, 2001) |
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Labeling Recommendations for Single-Use Devices Reprocessed by Third
Parties and Hospitals; Final Guidance for Industry and FDA (issued 7/30/2001) |
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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 |
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Premarket Guidance: Reprocessing and Reuse of Single-Use Devices;
Draft Guidance for Industry and FDA Staff (6/1/01) |
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Guidance on Adverse Event Reporting for Hospitals that Reprocess Devices
Intended by the Original Equipment Manufacturer for Single Use - Dated
April 24, 2001 |
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Enforcement Priorities for Single-Use Devices Reprocessed by Third
Parties and Hospitals - August 14, 2000 |
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Reprocessing and Reuse of Single-Use Devices: Review Prioritization
Scheme (Draft)- February 8, 2000 |
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Labeling Reusable Medical Devices for Reprocessing in Health Care
Facilities: FDA Reviewer Guidance - April 1996 |
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FDA Proposed Strategy on Reuse of Single-Use Devices - Updated November
1, 1999 |
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Compliance Policy (CPG 7124.16) Section 300.500 Reuse of Medical Disposable
Devices - September 24, 1987
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Letters |
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Letter to Hospitals Re: Changes in Enforcement of FDA's Requirements
on Reprocessing of Single-Use Devices (Issued September 25, 2001) |
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Letter Requesting Hospitals to Volunteer for FDA Site Visits as Part
of a Pilot Program - Dated April 20, 2001, Expires
May 25, 2001 |
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Letter to Hospitals Re: Reprocessing of Single Use Devices - April
23, 2001 |
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Letter to Hospitals Re: Reprocessing of Single-Use Devices - September
28, 2000 |
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Letter Re: Commercial Reprocessors of Disposable Medical Devices -
Dated July 13, 1998 |
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Letter Re: Policies That May Apply to The Reuse of Single-Use or Disposable
Medical Devices - Dated December 27, 1995
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Standards |
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Reuse of Single Use Devices - Standards |
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