FDA Rejects Recommendation for More Thorough Device Approval Process

The Institute of Medicine (IOM) is an independent, nonprofit organization that works to provide unbiased and authoritative advice to the government’s decision makers and members of the public. At the request of the FDA, the IOM submitted a review of the FDA’s medical device unit and their medical device approval process in late July.

The IOM found the fast-track approval process for medical devices, called 510(k), is “fatally flawed” and should be replaced because it does not adequately protect patients. The 510(k) program allows medical devices to get to market faster through an expedited review process if they are “substantially equivalent” to an existing product. Proponents of the program, namely the medical device manufacturers, feel that the 510(k) program benefits the public by allowing helpful devices to reach them more quickly. Critics say the accelerated 510(k) process is too widely used and leads to inadequate testing for some risky devices, citing the various devices recently pulled from the market after dangerous side effects were discovered.

The IOM recommended a more thorough approval process in order to ensure the safety of medical devices approved for public use by the FDA, “What we are recommending is that the 510(k) is fatally flawed in terms of it not evaluating safety and effectiveness of a device,” said Dr. David Challoner, chairman of the IOM’s committee. The FDA quickly responded by rejecting the recommendations of the IOM, “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,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

A change in the medical device approval process would raise the costs for device makers with pre-market and post-market device reviews. The device manufacturers have lobbied heavily to have Congress and the FDA ignore the recommendations of the IOM and to encourage the continued use of the 510(k) expedited review process. This proves that device manufactures are willing to put their profits ahead of public health concerns and, once again, the FDA is willing to side with the manufacturers.

Additional information on the IOM’s report can be obtained online: (http://www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx)