The Food and Drug Administration's new acting director at the Center for Devices and Radiological Health (CDRH) has set up an internal working group and given the Institute of Medicine a $1.3 million grant to study its troubled medical device approval program. The key question for the study, due in 2011, will be reform of the 510(k) process established in 1976, which allows device manufacturers to avoid rigorous FDA reviews when when their new devices are deemed substantially similar to an already approved device.

The process has been under fire since its inception. Many of the older devices, approved in earlier era, never received careful reviews by the FDA.

The process has also been prone to political pressure. In a widely reported recent case, Regen Biologics of Hackensack, N.J. used four local Congressmen to pressure then FDA commissioner Andrew von Eschenbach to approve a collagen scaffold used in knee reconstruction under the 510(k) process. Recently fired CDRH director Dan Schultz approved the shift. Sen. Charles Grassley has been investigating the affair.

"Our working group and the IOM's independent evaluation will help us determine how the 510(k) process can be improved to better support FDA's mission to protect and promote the public health," acting director Jeffrey Shuren said in a prepared statement.

The IOM is being asked to recommend reforms of the process. According to the release, the two principal questions are:

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