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Twenty-five high-risk medical devices that hit the market more than 33 years ago – and are still in use today – were never subjected to scientific scrutiny by the U.S. Food and Drug Administration (FDA). But that's about to change, The New York Times reports.
For the first time, devices as diverse as pacemaker parts and female condoms will be assessed using the contemporary analysis standards, including reports on safety and effectiveness from any company that manufactures them.
Since 1976, when Congress passed the Medical Device Amendments to the Food, Drug and Cosmetic Act, the FDA has been in charge of ensuring that all new medical devices get the job done and do so safely. The agency made plans to re-evaluate devices that were already on the market, but many have been de facto grandfathered in (so to speak) – even though they fall in the highest risk category ("those that support or sustain human life" per the FDA's Web site).
Pending the manufacturers' reports (due to the FDA 120 days after yesterday's announcement), the 25 devices will either be re-classified as lower risk or subject to today's pre-market approval process for new high-risk devices. That means that the manufacturer would need to present "scientific evidence of safe and effectiveness of its intended use," FDA spokesperson Peper Long says. The agency can – but isn't required to – do tests of its own.
The announcement comes three months after the Government Accountability Office (GAO) recommended that the FDA revisit the safety of these devices. Since 1994, the agency has reviewed and made recommendations on 124 other pre-1976 medical devices.
Here's a list of the devices that are up for review.
Image of a pacemaker in an x-ray © iStockphoto/Suljo
