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GUIDANCE DOCUMENT

Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals Final Guidance for Industry and FDA July 2001

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The “Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA” document provides guidance to third party and hospital reprocessors about their responsibility 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 are subject to all the regulatory requirements currently applicable to original device manufacturers.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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