The FDA has scheduled a public meeting on February 18, 2010, to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the US. The FDA receives more than 3,000 510(k) submissions each year.
The FDA claims that the public notice for the meeting will appear in the January 27, 2010 Federal Register. In September 2009, the agency had asked the Institute of Medicine (IOM) to conduct a comprehensive study of the process. The IOM study is not expected to conclude until March 2011.
In the meantime, the FDA has convened its own 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 will support the efforts of the agency’s internal working group.
At the meeting, FDA staff will present a brief overview of the challenges the agency has faced, organized in four categories like issues related to predicate devices, which are previously cleared devices that may support a manufacturer’s claim of substantial equivalence, 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.
Each of the four overview presentations will be followed by an open comment session. The meeting will close with a public roundtable discussion between FDA staff and selected participants representing a range of constituencies.