FDA to Discuss Changes to 510(k) Medical Device Approvals

The Medical Device Approval program, known as the 510(k), which quickens US approvals of some <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">medical devices, might be experiencing a change, says Reuters. Tomorrow, a meeting at the U.S. Food and Drug Administration (FDA) will be looking at the program.

Many consider the program controversial and moving beyond its original intent, which has led to problems with approved medical devices, noted Reuters. Tomorrow’s meeting will discuss key challenges related to pre-market notification, or the 510(k) process, used to review and clear certain medical devices marketed in the US. The FDA receives more than
3,000 510(k) submissions annually.

As we have previously written and the Associated Press (AP) noted last year, scientists under former medical device head, Daniel Schultz, claimed, “they were pressured to approve certain products” against their best judgment. It was a nine-scientist letter that added to the call for reform at the agency. Following the letter, a number of lawmakers called on the FDA to investigate the alleged corruption, reported the AP. Schultz who managed the division for five years, ultimately resigned.

Earlier last year we wrote that many critics of the FDA had long complained of safety problems, corruption, conflicts of interest, and budgeting and system problems that appeared to be routine at the agency under the former administration. With the Obama administration, new leaders were put in place and safety became an issue of importance at the FDA.

The FDA convened an internal working group to evaluate and improve the quality and consistency of its decision-making in the 510(k) process as well as its program administration. “It’s been more than 30 years since the establishment of the pre-market 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, 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 adopted in response to a high volume of submissions; and issues related to post-market surveillance and new information about marketed devices.

Reuters explained that the FDA classifies medical devices into three categories, which are determined by risk and with Class III representing the highest risk level. These devices, said the FDA, usually need pre-market approval and include heart valves and intraocular lenses. Class I and II devices present lower risks and include devices such as adhesive bandages and wheelchairs.

Jeffrey Shuren, new head of FDA’s Center for Devices and Radiological Health, said it was seeking input on the accelerated approval process, wrote Reuters. Meanwhile, Diana Zuckerman, president of the advocacy group National Research Center for Women & Families, stated that current standards for determining if a new device is equivalent to an approved device are “too loose to assure safety or effectiveness…. Our center regularly hears from patients and consumers who were harmed by LASIK, surgical mesh, bladder slings and other products that were not adequately tested prior to being sold,” quoted Reuters.