The commercial 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 the Resources sidebar.