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FDA To Improve Review Path For Medical Devices

January 20, 2011

The US Food and Drug Administration (FDA) announced Wednesday it plans to update its 35-year-old system that is used to approve most medical devices, which has come under increased criticism from public safety advocates.

The agency announced several changes it plans to make this year, including reorganizing the review process for some low-risk devices. But regulators said they will delay a decision on most drastic proposals, which would give the government more power over device makers.

The proposals, supported by most public safety groups, included giving the FDA clear power to revoke approval for products that prove ineffective or unsafe. Another major proposal would have established a new subset of devices that would require more medical data before gaining approval for the market.

But those proposals, released for public comment last summer, received much opposition from device manufacturers, and the FDA said in its report “that implementing them may be problematic.”

AdvaMed, the device industry’s main trade group, opposed the changes, saying they would make device reviews longer and more expensive, hurting innovation and endangering jobs.

AdvaMed represents most larger device firms including Medtronic Inc, Stryker Corp, and Johnson & Johnson.

Stephen Ubl, president of AdvaMed, said the announcement is “a good first step that will address some of the major problems with the program.”

But Dr. Diana Zuckerman of the National Research Center for Women and Families said the FDA’s plan suggests “industry lobbyists won, and the public lost.”

“Today’s FDA report gives the impression that FDA backed down on several safeguards as a result of unfavorable comments,” Zuckerman told The Associated Press (AP) in a statement. “FDA decisions should not be based on a popularity contest, especially since lobbyists rig the results.”

The FDA said it will allow guidance from the Institute of Medicine before it makes a final decision on the sweeping changes. The group, which advises the government on medical issues, is expected to make its recommendations later this summer.

The government’s so-called 510(k) system for devices was created in 1976 to grant manufacturers quick approval for devices that are similar to those already on the market. It is popular among manufacturers because it is a much faster process and a cheaper path toward marketing than the review process for novel devices, which must undergo thorough medical testing.

Critics of the 510(k) system say that many high-risk devices, such as pacemakers, are increasingly slipping through the process without any significant testing or scrutiny.

The 510(k) system is responsible for as many as 4,000 devices being cleared every year, while only about 50 devices are approved under the more strict process.

The FDA acknowledged last October that a knee repair device cleared under the 510(k) system in 2008 should have never been approved. The FDA’s top two device regulators who oversaw the review of the device have since left the agency.

The FDA said beginning in March it will make 25 changes to the 510(k) review process, including establishing a database with photos and safety labeling for all devices, clarifying when companies must submit clinical data for a 510(k) application, and establishing a council of experts within the agency to work on timely approvals for medical devices.

Medical device execs applauded the FDA for not making significant alterations to the system. “The fact that they are not going to take on more than they should right now, and deferring some of the tougher proposed changes to the appropriate guidance process, was a constructive outcome,” Bill Hawkins, chief executive of Medtronic, told AP.

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