FDA Web Links
The third-party reprocessing industry in the United States is among the most stringently regulated semgents of the medical device industry. For information on regulation of reprocessing:
- FDA Basics website
- FDA’s Reuse website
- FDA’s MDUFMA (Medical Device User Fee and Modernization Act) Web Site
- FDA’s 2002 survey of U.S Hospitals and Reprocessing: FDA Survey on Reprocessing
- FDA’s Guidance Document – Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals
- Search FDA’s 510(k) Database for Reprocessed Devices that have Received FDA Clearance
