The Institute of Medicine (IOM) of the National Academy of Sciences was commissioned by the Food and Drug Administration (FDA) to evaluate the 510(k) clearance process for medical devices and to make recommendations directed toward improving regulation of these devices. The IOM is a widely respected organization that assembles experts to study a range of health-related issues, often at the request of government agencies.
The 510(k) process allows manufacturers to market new devices without clinical testing for safety and efficacy if they were shown to be "substantially equivalent" to devices marketed before passage of the 1976 Medical Devices Amendment Act. As a result, many TMJ patients had devices made of synthetic materials, for example, silicone and Proplast-Teflon, which broke down and caused serious complications.
In 2011 The TMJ Association (TMJA) submitted a written statement to Congress concerning TMJ implant devices and the FDA’s 510k approval process. Additionally, Terrie Cowley, President of The TMJA, attended the April 13, 2011, Senate Congressional Hearing entitled, "A Delicate Balance: The FDA and the Reform of the Medical Device Approval Process." We encourage you to read the TMJA’s written statement and summary and recommendations submitted and included in the Congressional Hearing.
The IOM’s report on medical devices was released, on July 29, 2011. In the report the IOM committee concluded that the 510(k) process "lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and, furthermore, that it cannot be transformed into one."
The FDA released a statement in response to the IOM's recommendation to scrap the 510(k) process. “FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. FDA is now seeking public comments through a Federal Register notice. The TMJA submitted comments on the 510(k) process concerning TMJ implants and encourages patients to do so as well.