AEDs Among Devices Subject to New FDA Review
The Food and Drug Administration yesterday directed manufacturers of 25 types of medical devices marketed prior to 1976 to submit within 120 days safety and effectiveness information so FDA can evaluate the risk level for each type of device. Devices found to be of high risk to consumers will be required to undergo the agency's most stringent premarket review process, the agency said. This is the first step toward completing the review of Class III (premarket approval) devices that predate the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976, the law authorizing FDA to review new medical devices.
The 25 device types include external and implantable pacemaker pulse generators, pacemaker programmers, automated external defibrillators, and electroconvulsive therapy devices. FDA's notice says manufacturers must submit for devices covered by the order a summary of, and citation to, "any information known or otherwise available to them respecting the devices, including adverse safety and effectiveness data that has not been submitted under section 519 of the act." The agency spelled out how manufacturers who are or are not aware of information that would support reclassifying their devices as Class I (general controls) or Class II (special controls) should submit the information.
The agency noted there is "reasonable assurance that a device is safer when it can be determined, based upon valid scientific evidence, that the probable benefits to health from use of the device for its intended uses and conditions of use, when accompanied by adequate directions and warnings against unsafe use, outweigh any probable risks."