The U.S. Food and Drug Administration (FDA) is soliciting public comments regarding last week's report on its 510(k) process for regulating medical devices.
Produced by the Institute of Medicine (IOM) and released last Friday, the report sharply criticizes the 510(k) process, deeming it inadequate for its purpose. It indicates that in particular, the process by which new 510(k) applications are compared to previously cleared devices is “flawed” and, as such, should be eschewed in favor of another approach.
The IOM executed the report at the FDA’s behest. The effort represents part of a regulatory review process initiated by the agency in 2009. As a next step in this process, the FDA plans to accept public comment on the report through September 30, 2011.
To comment on the report online, click here: http://www.regulations.gov. Written comments should be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room1061, Rockville, MD 20852. Comments should reference “FR Doc No: 2011-19353”.
To read the report, click here: http://www.iom.edu/Activities/PublicHealth/510KProcess.aspx.