Legislation/Regulation

The third-party reprocessing industry is subject to a stringent, comprehensive regulatory scheme. Reprocessors are, in many cases, required to include in their premarket submissions to FDA a whole category of data that OEMs are not required to submit. Specifically, reprocessors are, in many cases, required to include validation data regarding cleaning, sterilization, and functional performance to show that the reprocessed device will remain “substantially equivalent” to the original device.

For a full description of the 2000 FDA guidance on  reprocessing as well as subsequent FDA guidance on cleaning, functional testing,  sterilization and data requirements, see:

FDA Guidance Docs 

FDA’s Guidance Document – Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals

FDA’s Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices – Guidance for Industry and FDA Staff

Testimony of Dr. Daniel Schultz, Director, CDRH, FDA (September 26, 2006)