US FDA Guidance Gives Best Practices For Bench-Test Reports

A new FDA draft guidance makes recommendations on what information medical device sponsors should include in complete test reports for nonclinical bench-testing as part of pre-market submissions.

A new draft guidance document from US FDA compiles the agency’s recommendations on how sponsors should format complete test reports from nonclinical bench-testing for inclusion in medical device submissions.

The document doesn’t include any new guidelines, FDA says; instead, it gathers recommendations made across a range of technical guidance...

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