The FDA Seeks Comments on Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions

The FDA Seeks Comments on Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions

Today, the FDA issued new draft guidance, Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions.

This guidance describes recommended information to be included in complete test reports for non-clinical bench testing that medical device manufacturers may submit in support of their premarket submissions. The FDA believes the availability of this information can help medical device manufacturers and FDA reviewers streamline the review process of new medical devices, while meeting the statutory requirements for clearance or approval. These recommendations are not intended to constitute new policy. They reflect recommendations previously included in multiple individual draft and final CDRH premarket technical guidance documents and are consistent with review feedback for premarket submissions when complete test reports are necessary.

Comments on the draft guidance may be submitted to Federal Register docket number FDA-2018-D-1329 until July 30, 2018.

If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or atdice@fda.hhs.gov. 

Food and Drug Administration 
Center for Devices and Radiological Health