List of Reusable Devices Needing Cleaning Instructions
As required by the 21st Century Cures Act, FDA has published a list of reusable medical devices which must include in their 510(k) submissions instructions for use that have been validated and validation data regarding cleaning, disinfection, and sterilization, for which a substantial equivalence determination may be based. The list is in a Federal Register notice to be published 6/9.
The notice says the agency “believes reusable devices must be designed for adequate reprocessing and safe reuse, with comprehensive and clear instructions for effective reprocessing procedures for use by healthcare facilities that reprocess these devices.” It says it believes that a majority of manufacturers for the reusable devices listed in the notice already are conducting validation of their reprocessing instructions because FDA already has provided recommendations for reprocessing validation in relevant FDA documents.