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The agency is examining
its own approval processes

FDA to Hold Public Meeting on Medical Device Premarket Clearance Process

by Astrid Fiano , DOTmed News Writer
The U.S. Food and Drug Administration (FDA) has announced a public meeting Feb. 18, 2010, to discuss the challenges in the premarket notification (510(k)) process, which reviews and clears certain medical devices marketed in the United States. The FDA says it receives more than 3,000 of the 510(k) submissions each year.

Recently, the agency has been the subject of critical review in the professional publications Journal of the American Medical Association and the American Journal of Therapeutics. In the JAMA study, researchers from the University of California found that "Premarket approval of cardiovascular devices by the FDA is often based on studies that lack adequate strength and may be prone to bias." The American Journal of Therapeutics found that "Poorly defined safety and effectiveness end points, poor patient accounting, and incomplete collection of important patient comorbidities make device safety and effectiveness assessments more challenging. Women, pediatric, and nonwhite populations are underrepresented in premarket cardiovascular clinical trials."

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The FDA says that in September 2009, it requested that the Institute of Medicine (IOM), an organization established by the National Academy of Sciences, conduct a comprehensive study of the premarket notification process. The IOM study should conclude in March 2011. The IOM is convening a committee to answer these questions: Does the current 510(k) process optimally protect patients and promote innovation in support of public health; and if not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?

The FDA has also convened an internal working group to "evaluate and improve the quality and consistency of the agency's decision-making in the 510(k) process as well as its administration of the program." The February meeting is part of the efforts of the agency's internal working group.

"It's been more than 30 years since the establishment of the premarket notification process for medical devices," said Jeffrey Shuren, M.D., J.D., the new director of FDA's Center for Devices and Radiological Health, in an FDA press release. "We are looking forward to hearing from the public on issues related to this program to help us improve it."

The FDA says that during the meeting, agency staff will have presentations on challenges the agency has faced: issues related to predicate devices; issues related to new technologies and scientific evidence; issues related to practices the FDA has adopted in response to a high volume of submissions; and issues related to postmarket surveillance and new information about marketed devices.

The public notice for the meeting will appear in the Jan. 27, 2010 Federal Register. The meeting will take place at the Hilton Washington, D.C./North Gaithersburg, in Gaithersburg, MD. The meeting will also be Webcast live at The FDA will accepting written or electronic comments by March 5, 2010.

Adapted in part from an FDA press release.

The JAMA article:

The American Journal of Therapeutics article:


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