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...
You may also be interested in...
Draft Guidance On PMA Annual Reports Focuses On Device Modifications
A draft guidance detailing what FDA expects manufacturers to include in annual reports for PMA-approved devices is less burdensome to industry than expected
Draft Guidance On PMA Annual Reports Focuses On Device Modifications
A draft guidance detailing what FDA expects manufacturers to include in annual reports for PMA-approved devices is less burdensome to industry than expected
CDRH Airs Ideas For Enhancing Manufacturers’ Annual Reports
Participants at a Feb. 8 workshop on postmarket issues debated how much information should be included in PMA annual reports, with CDRH representatives pushing for more thorough data submissions and industry stakeholders worrying that such an approach could prove burdensome