The FDA receives more than 3,000 510(k) submissions each year, according to the release. The aim of the 510(k) process is to make safe and effective devices available to the consumers and to promote innovation in the medical device industry. The FDA cites drastic changes in technology and the industry as reasons for reevaluating the process. In September 2009, the Institute of Medicine was asked to conduct a comprehensive study of the process, which is not expected to conclude until March 2011.
The FDA has meanwhile created 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, which was created 30 years ago, according to the release.
At the meeting, FDA staff will highlight for areas in which the agency has faced challenges in the program: 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.
An open comment session will follow each of the presentations on the four overview areas, according to the release. The meeting will close with a public roundtable discussion between FDA staff and selected participants representing a range of constituencies.
Information on the meeting times and location is available in the news release. Interested parties should register by 5 p.m. on Feb. 12, 2010. The FDA is accepting written or electronic comments through March 5, 2010.
Read the FDA’s release on the 510(k) premarket notification process.
