The federal Food & Drug Administration is gearing up to review 25 types of medical devices made before 1976, the year the watchdog agency got its brief to review new medical technologies.
Makers of the devices will have to submit safety and effectiveness data to the FDA within 120 days, which it will use to evaluate the risk level for each device type.
If found to be “of high risk to consumers,” the devices will have to undergo “the agency’s most stringent premarket review process,” according to a press release.
The FDA started reviewing new medical devices 33 years ago, after the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976 passed into law. Devices made before then — some 149 types in all — were to have been classified according to risk and reviewed, a process the agency is just now completing.
The new requirements (PDF) apply to 25 so-called “Class III” devices the agency deems the most risky.
They include membrane lungs, cardiac balloons, bypass devices, pacemakers, blood pumps, defibrillators, dental implants, jaw prostheses, shunts, hemoperfusion products, electrotherapy and electro-convulsive devices, female condoms, certain pedicle screw and hip joint replacement systems, some shortwave diathermy and Iontophoresis devices and transilluminators for breast evaluation.
Here’s the full FDA list.