UPDATE: FDA To Review Medical Devices Marketed Prior To 1976

(Updates with additional information from FDA throughout, and AdvaMed comment.)

By Jared A. Favole
Of DOW JONES NEWSWIRES

WASHINGTON (Dow Jones)--The Food and Drug Administration wants companies to submit data on certain medical devices marketed prior to 1976 in an effort to determine their risk to consumers.

The agency wants safety and effectiveness data for devices that fall into 25 categories, according to an FDA press release Wednesday. Such devices include the female condom, spine products and various parts for pacemakers. Companies that make devices in these 25 categories include Zimmer Holdings Inc. (ZMH), Medtronic Inc. (MDT) and Johnson & Johnson's (JNJ) device unit, Cordis Corp.

The agency's move represents its first step toward completing its review of devices marketed before 1976, when a law passed giving the FDA authority to review new medical devices. The Government Accountability Office, the nonpartisan government watchdog, in January criticized the agency for taking more than 30 years to complete the review. In the interim, the agency approved more than 200 high-risk medical devices through a process designed for low and moderate-risk devices.

The FDA will review the data and classify the devices according to their risk. Class III devices, such as pacemakers, pose the most risk and must go through a lengthy review process under which a company must prove, usually with clinical evidence, a drug is safe and effective. Class I and Class II devices, which include tongue depressors and reading glasses, generally don't require clinical trials and can reach market if the company shows the device is similar to others already approved.

The companies have 120 days to submit data. If the FDA classifies a device as Class III, the product will have to go through the agency's toughest review process for devices. A device that doesn't pass that review may get pulled from the market, said FDA spokeswoman Mary Long. She noted, however, that some devices may get lower classifications or may be safe and effective enough to pass the agency's strict review process.

Not all of the devices in the 25 categories were made before 1976. For instance, a device made by Oregon-based Biotronik Inc. to evaluate pacemakers was given clearance to go to market by the FDA in December 2007.

Janet Trunzo, executive vice president at AdvaMed, the device industry advocate group, said the group believes medical devices should be regulated according to their risk profile. She said "it needs to be clearly understood" that the FDA has already thoroughly reviewed the devices mentioned in the agency's announcement. Some of those reviews included clinical data, she said.

-By Jared A. Favole, Dow Jones Newswires; 202.862.9207; jared.favole@dowjones.com