FDA Releases Guidance for Devicemakers on Non-Clinical Bench Performance Test Reports

The FDA issued guidance recommending information to include in test reports for non-clinical bench performance testing included in premarket submissions such as premarket approval applications, humanitarian device exception applications and 510(k) submissions.

The complete test reports should contain the test’s objective, a description of test methods and procedures, pre-defined pass/fail criteria, test results and a discussion of the test’s conclusions. In the body of the submission, the sponsor should briefly describe all testing performed, including the test performed, objective of the test and a brief description of test methods and procedures.

The agency advised that complete test reports are not necessary for special 510(k)s or for tests which have been provided a declaration of conformity to an appropriate agency-recognized consensus standard.