Challenges related to premarket clearance process for medical devices: FDA schedules public meeting

Jan 23 2010

February Meeting will Complement IOM Study

The U.S. Food and Drug Administration announced today that it has scheduled a public meeting on Feb. 18, 2010, to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States. The FDA receives more than 3,000 510(k) submissions each year.

The public notice for the meeting will appear in the Jan. 27, 2010 Federal Register.

In September 2009, the agency announced it had asked the Institute of Medicine (IOM) to conduct a comprehensive study of the process. The IOM study is not expected to conclude until March 2011.

In the meantime, the FDA has convened 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. The February meeting will support the efforts of the agency's internal working group.

"It's been more than 30 years since the establishment of the premarket notification process for medical devices," said Jeffrey Shuren, M.D., J.D., director of FDA's Center for Devices and Radiological Health. "We are looking forward to hearing from the public on issues related to this program to help us improve it."

At the meeting, FDA staff will present a brief overview of the challenges the agency has faced, organized in four categories: 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.

Each of the four overview presentations will be followed by an open comment session. The meeting will close with a public roundtable discussion between FDA staff and selected participants representing a range of constituencies.

The Feb. 18 meeting will run from 8 a.m. to 5:30 p.m. at the Hilton Washington, D.C./North Gaithersburg, in Gaithersburg, Md. Those interested in attending or participating in the meeting must register by 5 p.m. on Feb. 12, 2010. The agency is accepting written or electronic comments by March 5, 2010.

The meeting will be Webcast live at http://www.ConnectLive.com/events/fda021810.

The 510(k) process was established under the Medical Device Amendments of 1976 to achieve two goals:

• Make safe and effective devices available to consumers; and
• Promote innovation in the medical device industry.

During the past three decades, technology and the medical device industry have changed dramatically, making it an appropriate time for the FDA to review the adequacy of the premarket notification program in meeting these two goals.
The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk and generally require premarket approval to support their safety and effectiveness before they may be marketed. Class III devices include heart valves and intraocular lenses.

Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices can only be marketed after the FDA has found them to be substantially equivalent to legally marketed devices that do not require premarket approval, based on FDA's review of submitted premarket notifications—also called 510(k) applications.

Devices that are not found by the FDA to be substantially equivalent to a legally marketed device, such as those with a new intended use or that have different technological characteristics that raise different questions of safety and effectiveness, require premarket approval.

For more information

FDA's Website on Premarket Notification (510k)
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

Institute of Medicine to Study Premarket Clearance Process for Medical Devices
FDA News Release: Sept. 23, 2009
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm183497.htm