The FDA to Evaluate 25 Medical Devices Marketed Before 1976 Without Premarket Approval
Filed under: Drugs & Medical Devices, FDA, FDA Center for Devices and Radiological Health
The FDA announced last week that they are requiring the makers of 25 medical devices marketed before 1976 to submit safety and effectiveness information regarding their devices. These devices were allowed onto the market without undergoing the current FDA testing and classification because they were first manufactured before the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976, and include many of the riskiest devices — defibrillators, pacemakers accessories, and heart valves.
Image by Paunami via Wikimedia Commons
The FDA classifies medical devices into three categories, with class III being the riskiest devices– as such, they require premarket approval. Currently, the 25 pre-amendment devices in question are class III, but based on the 1976 law these devices were not required to undergo premarket approval at the time.
The FDA will use the submitted safety and effectiveness data to review the devices and classify them into what they deem to be the appropriate risk category. According to the FDA, if a device is found to be a class III device, the manufacturer will need to submit a premarket approval application. If the device is moved to class I or II, it will not require premarket approval.
The FDA’s announcement comes after the Government Accountability Office reported in January that the FDA was not doing enough to thoroughly evaluate the safety and effectiveness of many medical devices marketed before 1976. They urged the FDA to review the devices and said that “it is imperative that FDA take immediate steps” to fix this review and approval process for devices.
Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health, said regarding the FDA’s new requirement:
We are taking the necessary steps to complete this very complex process while continuing to protect public health by thoroughly reviewing and evaluating all medical device submissions presented to the agency. New premarket notification submissions for devices of these 25 types will continue to receive an appropriate level of scrutiny to ensure safety and effectiveness.
This decision to evaluate these devices and further public safety comes after recent criticism of the agency, such as the opinion expressed publicly by a number of FDA scientists that the “FDA is fundamentally broken.” We have blogged about the much maligned agency on numerous occasions, with specific emphasis upon the Center for Devices and Radiological Health and a decline in medical device lab inspections.
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