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RAPS Annual Meeting In Brief

This article was originally published in The Gray Sheet

Executive Summary

PMA annual report warning: CDRH is "moving toward taking a more stringent review of annual reports," said Thinh Nguyen, CDRH's PMA program operations director, Oct. 19 at the Regulatory Affairs Professional Society annual meeting in Baltimore. The reports, which PMA holders must submit each year to FDA, include information on changes the manufacturer has made to the device as well as new clinical data that has come to light. "I would strongly recommend that you put additional time and effort into developing the best annual report possible before submitting them to the FDA," Nguyen said. He indicated that FDA has stepped up its issuance of deficiency letters to firms concerning annual reports....PMA guidances: FDA is expected to issue guidance documents on annual reports, PMA supplements and real-time application review by early 2006, according to Nguyen...
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