The “Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals” 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 singleuse devices are subject to all the regulatory requirements currently applicable to original equipment manufacturers, including premarket submission requirements (Sections 513 and 515 of the Act; 21 Code of Federal Regulations Parts 807 and 814).
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.