Consensus Standards: FDA Guidance Describes Recognition Process

The 13-page guidance document lays out what the agency looks for in deciding which consensus standards it can rely upon for premarket submissions.

Standards

New final guidance from the US Food and Drug Administration lays out how the agency plans to approach the recognition and withdrawal of voluntary consensus standards that can be used to support regulatory submissions.

The guidance document, which was issued on 15 September, finalizes a draft guidance issued in 2018.

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