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PMA filing checklist

This article was originally published in The Gray Sheet

Executive Summary

Financial disclosure requirements for clinical investigators (21 CFR 54) must be met for CDRH to file a premarket application, updated "1Checklist for Filing Decision for PMAs" specifies. Posted on the agency's website Jan. 24, the document also notes that environmental assessment under 21 CFR 25.20(n) is limited to first of a kind devices. Copies of key articles referenced in bibliographic sections should be submitted to FDA in English...

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