The Institute of Medicine (IOM) was commissioned by the Food and Drug Administration’s (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 IOM’s report on medical devices will be released on Friday, July 29, 2011. A public briefing will start at 11:00 a.m. EDT on July 29.
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. The result was that many TMJ patients had devices implanted that used synthetic materials for example, silicone and Teflon, which broke down and caused serious complications.
Last year The TMJ Association (TMJA) submitted a written statement to Congress concerning TMJ implants 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.
A July 28, 2011 article in the New York Times, Fight Over Medical Device Rules, Sight Unseen, says the medical device industry is finding fault in the IOM’s report in advance of the report release. According to the article, the IOM report will likely have a significant impact on patient safety, device effectiveness and speed at which new products reached the market. We encourage TMJ patients to read the article and post a comment.