The Institute of Medicine called for scrapping the Food and Drug Administration's 510(k) clearance process and remaking it from the ground up, as well as beefing up postmarket surveillance, in its long-awaited report released Friday.

The IOM, best known for changing hospital safety practices with its 1999 report, "To Err is Human," was tapped by the FDA in September 2009 to look into the agency's often-controversial 510(k) process.

The recommendations immediately drew the ire of device manufacturers, who said it came too late, as the FDA already released its own reform measures for the so-called "fast-track" device clearance process last summer.

"The report's conclusions do not deserve serious consideration from the Congress or the administration," Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association, a device company lobby, said in a statement.

Under scrutiny

The 35-year-old process is used to bring to market moderate-risk, Class 2 devices, including most radiological equipment. The FDA received about 4,000 510(k) submissions in 2009, the IOM said.

To pass, companies have to show a new device is similar to one already on the market, called a predicate device. Generally, they don't have to submit any clinical evidence. This worries patient advocates, who believe the process has allowed potentially dangerous or untested devices to reach the market.

For their part, manufacturers say a streamlined process -- like the 510(k) -- is important for getting innovative, life-saving devices to the public, but they complain the 510(k) process has slowed considerably in recent years, and the decision-making behind it is often arbitrary and opaque.

But the IOM, in its 227-page report, comes down closer to the side of patient advocates. The 12-panel group of assorted academics, radiologists, surgeons and lawyers said the process was not able to gauge the safety of a device, nor did it promote innovation.

"The committee concludes that the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and, furthermore, that it cannot be transformed into one," the IOM said in a summary of the report.

For one, the group said predicate devices are often poor models, as they include ones from before 1976, when the FDA began regulating devices, and those devices were never properly assessed for safety or effectiveness.

The IOM also judged that the 510(k) process does not require products to be innovative, so it cannot be said to "reward innovation."

"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.