Reusable Devices Requiring New Validation Data

The June 9, 2017 Federal Register identifies reusable medical devices that require “validated instructions for use” and “validation data requirements” in premarket notifications, i.e., 510(k)s.

The requirement comes from the 21st Century Cures Act, Section 3059 Cleaning Instructions and Validation Data Requirement, which says that FDA shall identify and publish a list of reusable device types for which 510(k) submissions are required to include (A) instructions for use and (B) validation data regarding cleaning, disinfection, and sterilization.

The Federal Register notice cited above contains the list. In addition, FDA-CDRH update the final guidance document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Appendix E, updated on June 9, 2017, contains the list which includes about 40 product codes.