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PMA submissions up almost 60% to 70 applications in FY 1997 - - ODE annual report.

This article was originally published in The Gray Sheet

Executive Summary

PMA SUBMISSIONS INCREASE NEARLY 60% TO 70 APPLICATIONS IN FY 1997, according to the annual report released by FDA's Office of Device Evaluation the week of Feb. 2. The 70 premarket approval applications received in fiscal year 1997 (ended Sept. 31) compares to 44 submitted in 1996 and is the most submitted since 1991. Of the 74 PMA-related filing decisions made during FY 1997, over 75% (58) were accepted for filing, the highest percentage in over 10 years. Nearly the same percentage of PMAs (72%, or 48) were approved, and 14 PMAs (21%) were deemed approvable.

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