FDA Issues Guidance on Premarket Submission Info on Performance Testing

The U.S. Food and Drug Administration (FDA) has issued a new guidance intended to help manufacturers of medical devices better understand the agency’s requirements regarding the submission of certain performance testing information in premarket submissions.

Issued at the end of April, the guidance “describes relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing.”  According to the FDA, non-clinical bench performance testing includes mechanical and biological engineering performance, bench tests using ex vivo, in vitro and in situ animal or human tissue, and any testing involving animal carcasses or human cadavers. It does not include biocompatibility evaluation, or validation testing related to sterilization, human factors, or software.

The results of non-clinical bench performance testing are typically required as part of a variety of premarket submissions for FDA review and approval, including premarket approval (PMA) applications, humanitarian device exception (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications and De Novo requests.

Read the complete text of the FDA’s guidance on performance testing information in premarket submissions.

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