March 5 deadline for comments about FDA 510(k) process

March 3, 2010

The public has until March 5 to submit comments related to presentations made at a Feb. 18 public hearing at which FDA officials discussed challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States.

Washington, DC

-The public has until March 5 to submit comments related to presentations made at a Feb. 18 public hearing at which FDA officials discussed challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States.

Presentations from the meeting are posted at

www.regulations.gov

; search for FDA-2010-N-0054. Electronic comments may be submitted to the docket. Written comments may be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

The FDA receives more than 3,000 510(k) submissions each year. Last year, the agency asked the Institute of Medicine (IOM) to conduct a comprehensive study of the process. The IOM study is expected to conclude in about a year.

In the meantime, the Feb. 18 meeting is expected to support the efforts of an internal working group convened by FDA 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. An agency task force is scheduled to announce recommended policy changes in June.