Draft Guidance On PMA Annual Reports Focuses On Device Modifications
This article was originally published in The Gray Sheet
A draft guidance detailing what FDA expects manufacturers to include in annual reports for PMA-approved devices is less burdensome to industry than expected
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The move is in line with the agency’s intention to focus on the total product life-cycle, such that the same staffers that review an original marketing submission will look at the safety and effectiveness of manufacturing changes.
PMA supplement guidance, finally?: "I'm going to go out on a limb and say it will be out by the end of the calendar year," Office of Device Evaluation Director Donna-Bea Tillman said Oct. 16 at the Regulatory Affairs Professionals Society (RAPS) annual meeting in Baltimore in reference to a highly-anticipated PMA product modification guidance. The guidance, which is expected to define specific PMA supplement types and lay out criteria for when to proceed with each, will replace a 1998 guidance on the topic that FDA removed from its website in 2005 (1"The Gray Sheet" May 30, 2005, p. 3). CDRH PMA Section Director Thinh Nguyen had told an audience at the 2005 RAPS meeting to expect the guidance in early 2006. "It's been a very difficult guidance. A lot of different people have had to see it and weigh in on it," Tillman said. "We know that the industry wants that guidance"...