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A Promise Kept? FDA Gives Some Leeway On 'Promissory' Statements In Consensus Standards Final Guidance

Executive Summary

A final guidance from US FDA details when underlying data or supporting documentation must accompany a declaration of conformity to a consensus standard in a pre-market submission, and it offers a bit more wiggle-room than the agency previously proposed on the prospect of a promissory note pledging future conformance with a standard.


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