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FDA 30-day sign-off on third-party device decisions planned for pilot program.

This article was originally published in The Gray Sheet

Executive Summary

THIRD-PARTY DEVICE REVIEW PILOT: FDA SIGN-OFF WITHIN 30 DAYS on 510(k) decisions made by third-party groups likely will be a performance goal for the pilot program. Adopting a suggestion from the Health Industry Manufacturers Association ("The Gray Sheet" June 26, p. 4), FDA is expected to set itself a 30-day deadline for reviewing and signing off on third-party "substantial equivalence" determinations.
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