"It is unclear-and the committee concludes that it is indeterminable, given current information- whether the 510(k) process over the last 35 years has had a positive or negative effect on innovation. To answer this question, the FDA should commission an assessment to determine this effect," the IOM said.

Postmarket surveillance

Another main point of the IOM's report was strengthening postmarket surveillance -- reviewing devices that have already been released.

"No premarket regulatory system for medical devices can guarantee that all new medical devices will be completely safe and effective when they reach the market. Robust postmarketing surveillance is essential," the IOM said.

The group asked the FDA to better clarify its powers when it comes to seizing or banning devices already released. Earlier, the agency said there were limitations, but the IOM said the FDA has not clarified what those were.

Nonetheless, despite its criticisms, the IOM emphasized it did not believe most devices cleared by by the process were a menace to the public, or that they didn't work.

"The continual use of many of these devices in clinical practice provides reason for a level of confidence in their safety and effectiveness," the group said.

FDA, others respond

For its part, the FDA said Friday it would open a public comment period to get feedback on the report, and that many of the recommendations "parallel" ones already underway at the agency. Still, the FDA said some of the changes appeared to require "congressional action," and that it did not think the 510(k) process should be totally destroyed.

"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.

Some patient advocates also approved the measure. In an IOM press conference, Diana Zuckerman, president of the National Research Center for Women & Families and a noted critic of the 510(k) process, congratulated the group for its "courage and [its] cutting right through to the heart of the matter, that safety and effectiveness are the key, and that's what's being lost here."

But device manufacturers were disappointed, with the primary sentiment that the report comes too late, as the FDA had already embarked on a series of 510(k) reforms, starting last year.

“The 510(k) reform effort has been underway for well over a year and IOM’s recommendations come very late in the process, falling far outside of the current conversation,” said Dave Fisher, executive director of the Medical Imaging & Technology Alliance, in a statement.




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