More PMA Reviews Deferred As Device Center Meets MDUFMA Head-On
This article was originally published in The Gray Sheet
Executive Summary
CDRH reviewers are placing more PMAs and 510(k) applications on hold in an effort to meet MDUFMA performance goals, according to the center's chief Donna-Bea Tillman
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PMA Supplement Guidelines At Last, But Industry Might Not Be Satisfied
FDA issued a long-awaited PMA supplement decision-making draft guidance March 9, sparking a round of applause from industry members attending AdvaMed's annual meeting in Chandler, Arizona
Regulatory Affairs Professionals Society Meeting In Brief
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"...