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Reporting of Device Mechanical Testing for FDA Submissions

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If you're performing mechanical or performance testing on your devices, you may want to review this new FDA guidance to make sure that expected information is included in test reports and protocols intended for submissions. Presenting testing in the proper format will make the submission process faster and smoother.

See the link below for the guidance titled "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions":

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-format-non-clinical-bench-performance-testing-information-premarket

 

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