FDA Seeks Input on 510 (k) Process

The Food and Drug Administration is seeking industry comment on an initiative to strengthen the Center for Devices and Radiological Health's premarket notification process, also known as the 510 (k) process for approving new or upgraded medical devices for commercial use.

The FDA, in a notice to be published Jan. 27 in the Federal Register, asks for comment on a series of questions, including ways to improve its searchable online database of approved devices.

Database questions include: How effective is the 510 (k) database and search engine in helping prospective submitters find and evaluate the adequacy of predicate devices for 510 (k) submissions, and write substantial equivalency rationales? What aspects of the database and search engine are useful? What could be improved? What, if anything, should be added to the 510 (k) database and search engine?

Public comments are due by March 5. The agency will hold a public meeting on Feb. 18 in Gaithersburg, Md., to gain additional information.  The notice is available for viewing at federalregister.gov/inspection.aspx. It will be in the Federal Register on Jan. 27 at gpoaccess.gov/fr/index.html.

--Joseph Goedert