PMA reports allowed on bienniel basis under Reinventing Government initiative.
This article was originally published in The Gray Sheet
Executive SummaryPMA REPORT SUBMISSIONS ON BIENNIAL RATHER THAN ANNUAL BASIS is among FDA device reporting deadline modifications proposed by the agency in response to President Clinton's April request to reduce the frequency of reports under federal regulations. In a summary of a report of HHS reform initiatives released the week of Sept. 4, the department said that FDA "can extend to biennial" the current annual time frame for submission of postmarket reports for devices with cleared premarket approval applications.
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