Zdrowie i gospodarka · 01/06/2001

FDA Releases Draft Guidance on Reprocessing and Reuse of Single-Use Medical Devices

The FDA has made available a draft guidance document outlining premarket requirements for reprocessing and reusing single-use medical devices, aimed at the medical device industry, third-party reprocessors, and hospital reprocessors, as well as CDRH staff responsible for evaluating submissions and enforcing regulations.