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Final Bench Testing Guidance Clarifies FDA Expectations

 
• By Elizabeth Orr

Device developers are getting new guidance about what the US FDA wants to see from non-clinical bench testing via a final guidance document issued on 25 April.

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• Source: Shutterstock

Newly finalized guidance from the US Food and Drug Administration lays out how device developers should present information from non-clinical bench performance testing in premarket submissions.

The 25 April document includes formatting and content recommendations for test report summaries, test protocols, and complete test reports...

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