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)?
On April 30, 2003, FDA published a Federal Register notice that included a list of critical2 reprocessed single-use devices that are already subject to 510(k), but for which the manufacturer must now submit “validation data . . . regarding cleaning and sterilization, and functional performance” to show that the reprocessed device “will remain substantially equivalent . . . after the maximum number of times the device is reprocessed as intended” by the person who submits the 510(k). For a reprocessed single-use device that obtained 510(k) clearance prior to April 30, 2003, the manufacturer must submit validation data to FDA by January 30, 2004 if the device is to remain on the market. Any new 510(k) (any 510(k) submitted after April 30, 2003) for a device on this list must include validation data.
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?
