FDA meeting to review 510(k) device process

Jan 21, 2010

The U.S. Food and Drug Administration (FDA) has scheduled a meeting in February to review its 510(k) premarket notification process for reviewing and clearing medical devices.

The FDA last week said that the February 18 meeting is part of a possible overhaul of the 510(k) process. It's been more than 30 years since the 510(k) process was established, and in the meantime technology and the medical device industry have changed dramatically, the agency noted.

At the meeting, FDA staff will present overviews of the challenges the agency has faced, organized into four categories:

Issues related to predicate devices, which are previously cleared devices that may support a manufacturer's claim that a new product is substantially equivalent to a product that has already been cleared
Issues related to new technologies and scientific evidence
Issues related to practices the FDA has adopted in response to a high volume of submissions
Issues related to postmarket surveillance and new information about marketed devices

Each presentation will be followed by a comment period, and the meeting will close with a public roundtable discussion between FDA staff and selected meeting participants.

The FDA has been criticized within the radiology industry for confusion regarding whether some types of medical imaging technology -- such as computer-aided detection (CAD) software and full-field digital mammography (FFDM) systems -- should be covered under the 510(k) process or the more rigorous premarket approval (PMA) route. New CAD and FFDM product approvals have largely ground to a halt in the past several years.

The FDA noted that it has asked the U.S. Institute of Medicine (IOM) to conduct a study of the 510(k) process, but the review is not expected to be completed until March 2011.

The public notice for the meeting will appear in the January 27 edition of the Federal Register.

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