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FDA Issues Guidance on Non-Clinical Bench Performance Test Reports

Posted 31 May 2018 | By Michael Mezher 

FDA Issues Guidance on Non-Clinical Bench Performance Test Reports

The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance providing recommendations to device makers on what should be included in complete test reports for non-clinical bench performance testing in premarket submissions.
 
According to FDA, non-clinical bench performance testing is done to assess aspects of device performance such as fatigue, wear and tensile strength, though which specific tests a device maker conducts will vary based on the type of device. FDA also clarifies that biocompatibility testing, sterilization and animal in vivo testing is not considered non-clinical bench performance testing.
 
Draft Guidance
 
The guidance applies to most types of premarket device submissions, including premarket approval (PMA), humanitarian device exemption (HDE), premarket notification (510(k)), investigational device exemption (IDE) applications and de novo classification requests.
 
However, FDA says that complete test reports are not necessary for Special 510(k)s or for tests done to conform to an FDA-recognized consensus standard.
 
FDA says that every premarket submission that contains complete test reports for non-clinical bench performance testing should include a summary report providing an overview of the tests.
 
For the test reports themselves FDA says sponsors should include a description of the test performed; the test’s objective; a description of the test methods and procedures; the pre-defined pass/fail criteria; a discussion of the test results; and a discussion of the conclusions drawn from the tests.
 
For 510(k)s, FDA also says that sponsors should ensure that the sample size selected for the tests and the conclusions drawn from them demonstrate substantial equivalence to a predicate device.
 
Guidance, Federal Register Notice

Categories: Regulatory News

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