FDA To Review Safety, Effectiveness of Some Older Medical DevicesFDA on Wednesday announced it will ask several medical device manufacturers to submit data detailing the safety and effectiveness of some of their products already available on the market, the New York Times reports. The manufacturers will have 120 days to submit the data (Harris, New York Times, 4/9).
The request stems from a January Government Accountability Office report that criticized FDA for continuing to use a 1976 review and approval process for high-risk, Class III medical devices that GAO said does not do enough to ensure that the products are safe and effective. Congress in May 1976 passed legislation to establish a three-tiered classification of medical devices. Class I and Class II devices generally were required to undergo the 510(k) review process, while most Class III items received a more rigorous premarket approval review. However, certain types of Class III devices that had been approved for the U.S. market before May 28, 1976, were exempt from the PMA review and still could be cleared through the 510(k) process. Congress in 1990 enacted the Safe Medical Devices Act, mandating that all Class III devices undergo the more rigorous PMA review process, even if they are similar to devices approved before May 28, 1976 (Kaiser Daily Health Policy Report, 1/16).
According to the Times, FDA did not complete that process of reclassification and had approved 27 types of Class III devices without the required PMA examination. The Times reports that "for decades" FDA continued to approve devices in these categories without requiring rigorous testing to prove their safety.
FDA already has launched a review for two of those devices. The agency's request is for data from companies that manufacture the other 25 types of devices (New York Times, 4/9). The request will cover automatic external heart defibrillators manufactured by Medtronic, Royal Phillips Electronics and Zoll Medical; dialysis catheters manufactured by Covidien; hip joints manufactured by Zimmer Holdings; spinal screws manufactured by Medtronic and Johnson & Johnson; a heart pump marketed by Abiomed; and several other groups of devices.
According to the Wall Street Journal, "[t]he move presents the possibility that the companies will have to pay for expensive clinical trials for products already on the market, unless they can persuade the agency to reclassify them as less risky" (Winstein, Wall Street Journal, 4/8). Mary Long, a spokesperson for FDA, did not specify a timeline for when the reclassification process for the older devices could be completed. "We have to review each device type separately," Long said, adding, "It will take some time." Industry groups believe that FDA will conclude that most of the devices are not risky enough to warrant additional review, according to the Times.
Meanwhile, consumer advocates say the agency's entire medical device review process needs to be overhauled. Diana Zuckerman, president of the National Research Center for Women and Families, said, "It's great that FDA is finally going to look at pre-1976 devices, but the bigger problem is the low standards for approving any and all devices without clinical trials or any proof of safety or effectiveness" (New York Times, 4/9). This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.