Renewed reports of complaints about metal-on-metal hip replacements have revived questions about the FDA 510(k) fast track medical device approval process.
Metal-on-metal hip products are considered Class III devices by FDA, and generally require submission and approval of a premarket approval (PMA) application prior to marketing. FDA, however, has historically allowed the devices in this product code to be marketed without the requirement of a PMA application, as they were marketed before May 28, 1976, or are substantially equivalent to devices that were marketed before May 28, 1976 or approved under a premarket notification 510(k) since May 28, 1976, when the Medical Device Amendments of 1976 were enacted. This abbreviated approval process allows “substantially equivalent” devices – such as metal-on-metal hip replacements – to be brought to market in a much shorter timeframe, and with less extensive pre-market testing, than the timeframe and testing required for new medical devices (i.e., devices that were not marketed before May 28, 1976).
In May, FDA invoked its authority under Section 522 of the Federal Food, Drug and Cosmetic Act to order manufacturers of metal-on-metal hip replacements to conduct post-marketing studies of patients who received the devices. The directive was motivated by reports of early replacement failures and adverse health effects in patients. The studies will be conducted by the manufacturers and, once completed, FDA will determine whether the device classification should (a) remain as Class III and require submission of a PMA or a notice of completion of a Product Development Protocol, or (b) be reclassified as Class I or II.
Although the outcome of FDA’s review is uncertain, one questions whether the focus should be broadened to include FDA’s 510(k) medical device approval process. Indeed, the same metal-on-metal hip replacements that are subject of the 522 Order are the same devices that complied with and were approved under 510(k), including under the abbreviated review process. From a potential liability perspective, compliance with the relevant federal regulatory requirements arguably should provide indicia of medical device safety and efficacy. Should these issues move to the litigation phase, preemption questions are likely to be raised. Regardless, these developments merit close attention and will be addressed here as they unfold.