PMA SUPPLEMENT REQUIREMENTS WILL BE CLARIFIED BY FDA
This article was originally published in The Gray Sheet
Executive Summary
PMA SUPPLEMENT REQUIREMENTS WILL BE CLARIFIED BY FDA in an upcoming notice of proposed rulemaking, the agency says in an April 25 Federal Register notice outlining HHS' semiannual regulatory agenda. The proposed rule slated for publication in June would "clarify when a [premarket approval application] supplement is required" and "result in fewer unapproved changes in devices," FDA says.
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