Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions.'' FDA has developed this document to describe relevant information that should be included in complete test reports for non-clinical bench performance testing provided in a premarket submission (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo classification requests). This draft guidance is not final nor is it in effect at this time.