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Guidance Issuing OfficeCenter for Devices and Radiological Health
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 hospitals 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 (SUDs) 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.