FDA issues draft guidance for electronic 510(k)s

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The U.S. Food and Drug Administration (FDA) has issued a draft guidance for electronic submission of 510(k) applications.

The guidance is part of a process the FDA has undertaken to develop electronic submission templates, a process the agency announced in February 2020. The agency believes that electronic submissions can help it better organize information in 510(k) submissions for scientific review.

The agency is taking comments on the draft document through November 28.

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