The Institute of Medicine (IOM), an independent nonprofit branch of the National Academy of Sciences, works to provide unbiased and authoritative advice to the government’s decision makers and members of the public. So when the FDA wanted to revise their approval process for medical devices, they asked IOM to review the process they’ve been using, called the 510(k) process.

The FDA asked the IOM to examine the process and answer two questions:

1) Does the current 510(k) process optimally protect patients and promote innovation in support of public health goals?
2) If not, what legislative, regulatory or administrative changes are recommended to achieve the goals of the 510(k) clearance process?

The questions were intended to settle conflicting concerns: some argue that medical device approvals need stronger safety protocols, while others argue that the industry is being crippled by the time-intensive process for bringing a new device to market.

In late July, the IOM published their findings and announced that they found the new fast-track approval process, called 510(k), “fatally flawed” and recommended that the FDA redesign it because it does not adequately protect patients.

The FDA designed the 510(k) program to try to get medical devices to market faster if they are “substantially equivalent” to an existing product. Medical device manufacturers argue that the 510(k) program benefits the public by allowing helpful devices to reach them more quickly. Critics say the accelerated process leads to inadequate testing for some risky devices, citing various devices such as defibrillators that needed to be pulled from the market after dangerous side effects were discovered.

The IOM recommended the FDA enforce a more thorough approval process in order to ensure the safety of medical devices approved for public use. ““It’s not clear that the 510(k) process is serving the needs of either industry or patients, and simply modifying it again will not help,” said Dr. David Challoner, chairman of the IOM’s committee.

The FDA quickly responded by rejecting the IOM’s recommendations. Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement: “The 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.”

A change in the medical device approval process would raise the costs for device manufacturers, so they 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.

The FDA has proposed changes, including the possibility of creating a new category of more risky devices that would require more data to win approval. But the IOM committee said the FDA should not waste its limited resources on changing the current program. Instead, the committee said the FDA should focus on developing a new framework.

In the month since the IOM’s report was released, no final decisions have been made.