FDA Supports Changing Medical Device Approval Process

FDA Supports Changing Medical Device Approval ProcessThe U.S. Food and Drug Administration is backing a program that allows for a change in its expedited review process for moderate-risk medical devices like hip implants, Bloomberg reports.

Currently, the FDA uses a process called 510(k), and this system is used to clear devices including x-ray machines and orthopedic implants. However, the Institute of Medicine (IOM) has suggested to the FDA that the agency abandon the program for a safer system.

According to the report by IOM, "a move away from the 510(k) clearance process should occur as soon as reasonably possible."

The 501(k) program is designed for devices that are new or modified but substantially equivalent to another device already legally marketed. This 35-year-old system allows low- to moderate-risk devices to be used after an inconsistent and unpredictable process, says the Journal of the American Medical Association. Physicians, consumers, and others in the industry have said that the process often overlooks safety.

As a result, the FDA has proven to be open to the possibility of change. The agency agreed to put the Institute of Medicine's suggestion up for public comment.

"We are open to additional proposals and approaches for continued improvement of our device review programs," Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, explained in a statement.

Shuren added, however, that the agency's current 510(k) process should not be eliminated entirely.

The first issues with the system were raised by stakeholders in September 2009, according to the FDA, and since then the agency has been committed to improving the program. The agency has already issued a draft guidance clarifying when a 510(k) is needed.

The agency hopes that the entire restructuring process will be complete by 2012.

Not everyone is on board with a change at the FDA, according to Bloomberg. Dave Fisher, executive director of the Medical Imaging and Technology Alliance told the news source that he believes approving IOM's change would inhibit innovative technology from clinical trials and thus, reaching patients, in exchange for technology that's already widely known.

"You don't need a clinical trial to know that a radiation therapy device, that its output will kill cancer cells," he told the news provider. "We know what will happen with an X-ray machine."