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In Brief: PMA announcement procedures

This article was originally published in The Gray Sheet

Executive Summary

PMA announcement procedures: Notices of approvals and denials of premarket approval applications will appear on the Center for Devices and Radiological Health home page beginning March 2, according to a Jan. 30 final rule published by FDA in the Federal Register. A quarterly list of reviewed devices and their status will be posted on the Internet, replacing the practice of publishing individual notices in the Register. FDA opted for the new format because "announcements can be placed on the Internet more quickly than they can be published in the Federal Register" and "the Internet is accessible to more people." Firms will continue to be allotted 30 days following the release of the list to petition the agency's decision on the PMA...
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