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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

Document issued on: July 9, 2002

This document contains three questions to be added to the 13 questions in 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, July 6, 2001.

U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of Health and Industry Programs Division of Device User Programs and System Analysis

Preface

Public Comment

Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.

For questions regarding the use or interpretation of this guidance, contact Lily Ng at 301-594-2812 or by email to lxn@cdrh.fda.gov.

Additional Copies

Additional copies are available from the Internet at http://www.fda.gov/cdrh/ohip/guidance/1408.pdf or CDRH Facts-On-Demand. In order to receive this document via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number 1408 followed by the pound sign (#). Follow the remaining voice prompts to complete your request.

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

BACKGROUND

On August 14, 2000, the Food and Drug Administration released a document entitled "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals" to provide guidance to third-party and hospital reprocessors about their responsibilities as manufacturers engaged in reprocessing devices labeled for single use under the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, and the Food and Drug Modernization Act of 1997. Third-party and hospital reprocessors of single-use devices (SUD) are subject to all the regulatory requirements currently applicable to original equipment manufacturers, including premarket submission requirements (Section 513 and 515 of the Act; 21 Code of Federal Regulations Parts 807 and 814).

Since its release on August 14, 2000, the agency has received numerous questions about the enforcement priorities guidance. The following questions and answers are meant as clarification of the original document. This guidance will be updated as the need arises.

The Least Burdensome Approach

We believe FDA should consider the least burdensome approach in all areas of medical device regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be found on the Internet at http://www.fda.gov/cdrh/ombudsman/

Question related to
APPENDICES

Question. What are the regulatory requirements for opened-but-unused SUDs reprocessed by a third-party (commercial) reprocessor?

Answer. The Food and Drug Administration's guidance document "Enforcement Priorities for SUDs Reprocessed by Third Parties and Hospitals" (dated Aug. 14, 2000), defined opened-but-unused single-use devices (SUD) as "single-use, disposable devices whose sterility has been breached or compromised, or whose sterile package was opened but not been used on a patient, that is, they have not been in contact with blood or bodily fluids." (Appendix B, page 40)

In section "C. Scope" of the guidance document, it states that the enforcement priorities do not apply to opened-but-unused SUDs. This means that at this time, FDA is not requiring third-party or hospital reprocessors of SUDs to submit PMAs (premarket approval applications) or 510(k)s (premarket notification submissions) for open-but-unused SUDs. However, FDA's existing policy for opened-but-unused SUDs that are reprocessed by third parties remains unchanged: opened-but-unused SUDs reprocessed by commercial reprocessors are subject to the Quality System Regulation (QSR).

Question related to
QUALITY SYSTEM

STERILIZATION

Question. Must a reprocessor of a single-use device (SUD) validate its cleaning/disinfection process if the device being reprocessed is not intended to be sterile?

Answer. Yes. Validation is needed because the results of the cleaning/disinfection process cannot be fully verified by subsequent inspection and testing. Furthermore, the fact that the device is nonsterile means there will not be a subsequent sterilization process to kill any contaminants remaining on the device after cleaning/disinfection.

Question related to
ENFORCEMENT DATES

Question. Since several extensions have been granted, what are the dates that hospital reprocessors of SUDs must meet?

Answer. The following tables summarize the regulatory requirements and the enforcement dates that apply to hospital reprocessors of SUDs.

DATES FOR MEETING
PREMARKET SUBMISSION REQUIREMENTS

*Provided that the reprocessor

(1) submitted a premarket notification by August 14, 2001;
(2) has not received a "not substantially equivalent" determination; and
(3) provides timely responses to FDA's requests for additional information.

DATES FOR MEETING
NON-PREMARKET REQUIREMENTS

Updated July 11, 2002

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