When will FDA require premarket reports for class III reprocessed single-use devices?
Related Questions
- When will FDA require validation data for reprocessed single-use devices that already require 510(k) clearance (i.e., devices that are not 510(k) exempt)?
- What sterilization activities does FDA expect in a hospital reprocessor that is reprocessing single-use devices (SUDs)?
- When will FDA require premarket reports for class III reprocessed single-use devices?
