FDA to change 510(k) process 25 ways

SAN JOSE, Calif. – The U.S. Food and Drug Administration identified 25 areas where it will make changes in 2011 to the so-called 510(k) program, the most widely used regulatory path for medical electronics devices.

The proposed reforms are among the least controversial of 55 recommendations the agency aired in a report in August. They included several nuggets of good news for industry such as a streamlined process for classifying low-risk products, greater training for FDA examiners and greater transparency into the FDA process.

The FDA deferred some of the most controversial issues to the Institute of Medicine, an independent, non-profit group. The IOM aims to release in June results of its own high-level review of the 510(k) program.

The news comes at a time when many medical electronics groups and executives complain the regulatory process in the U.S. has slowed and stiffer rules will hamper innovation. Industry sources characterized the FDA's latest moves as balanced, but noted the agency has yet to release details of its plans.

"It was heartening that the FDA listened to its constituents, retained what they need in authority but scaled back some proposals to be more balanced," said Susan Alpert, chief regulatory officer of Medtronic in an interview with EE Times.

Last week, Medtronic's chief executive said at an industry event that the FDA should lower not raise regulatory barriers to ensure U.S. companies don't lose a competitive edge.

The 510(k) program is used to speed regulatory approvals for devices that are similar to ones that have already passed FDA scrutiny.

"Much of the agency’s plan supports our long-standing position that the 510(k) process is fundamentally sound," said Stephen Ubl, chief executive of the Advanced Medical Technology Association (AdvaMed), an industry trade group. "The FDA’s plan drops or defers many proposals that would have significantly slowed patient access to new diagnostics and treatments and placed significant burdens on industry without corresponding health benefits," he added, speaking in a press statement.

The FDA deferred seven controversial issues to the IOM. They include a proposal to create a new Class IIb of devices, a move opposed by AdvaMed and others.

The FDA also deferred recommendations that it develop processes for revoking a 510(k) approval and for requiring studies of a device after it was launched on the market. In addition, it shelved a decision on whether FDA examiners could consider so-called "off-label use" of a device.

"Those issues are appropriate to put to the IOM which is looking broadly at the 510(k) program at a high level," said Alpert.