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FDA Guidance Looks At Benefit Vs. Risk In Certain 510(k)s

 
• By Elizabeth Orr

A newly finalized guidance document from US FDA explains how the agency will evaluate benefit and risk questions for substantially equivalent products with differing technological characteristics.

Risk Dial
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Developers of 510(k) products that have technological characteristics from their predicates are getting new information from USA FDA this week, as the agency finalizes a guidance document describing how benefit-risk considerations will be applied in that situation.

The agency hopes the 25-page document will help add consistency, predictability and transparency to the review process. It describes the agency’s process on some key scenarios, including when the...

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