Requirement for Validated Instructions for Use and Validation Data for Certain Reusable Medical Devices

Today’s Federal Register includes a list of reusable medical devices for which the FDA will require (1) validated instructions for use and (2) validation data regarding cleaning, disinfection, and sterilization in premarket notification submissions.  FDA is publishing this list in accordance with the requirements established by the 21st Century Cures Act.  This action ensures that the premarket requirements for these device types are clear and predictable which facilitates more efficient review of these 510(k)s. 

For additional information, refer to https://www.federalregister.gov/documents/2017/06/09/2017-12007/medical-devices-validated-instructions-for-use-and-validation-data-requirements-for-certain-reusable.

FDA guidance on Reprocessing Medical Devices in Health Care Settings (2015) contains information on the validation processing methods necessary to be reported in a 510(k) submission.  Appendix E of this guidance has been updated to include all device types listed in today’s Federal Register notice.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health