(STR Trade Report)
Rep. Edward Markey, D-Mass., and Sen. Jeff Merkley, D-Ore., have asked the Food and Drug Administration to overhaul and streamline its databases on recalls and 510(k) premarket notifications “to provide publically available and easily searchable information regarding the safety of [medical] devices that rarely undergo clinical trials in humans prior to being sold on the market.” The lawmakers noted that the improvements they are recommending would enhance the transparency of the 510(k) process, help manufacturers avoid using recalled devices as predicates that may put their own devices at risk for future enforcement action, and enhance awareness among the public and medical professionals of the potential dangers of medical devices that are based on flawed predicates. They asked the FDA to respond no later than Sept. 19.
According to the letter, the 510(k) process permits medical devices to be sold as long as the sponsor demonstrates that the product is similar, or substantially equivalent, to a legally marketed device (the predicate). As long as the sponsor shows that the new device is substantially equivalent in design, technology and intended use to the predicate, the FDA is generally required to clear it. Unfortunately, the letter states this requirement applies “even in cases where the new product contains the same flaws as an earlier model that had to be recalled by the manufacturer due to a fundamental design flaw.”
The two lawmakers said they believe the solution to this problem will require (a) enabling the FDA to reject clearance if a device repeats design flaws that have led to the voluntary recall of earlier products, as proposed in H.R. 3847, The Safety Of Untested and New Devices Act, and (b) providing device manufacturers, the public and medical professionals with better information about devices recalled for serious design flaws. They asserted that this greater transparency could be accomplished by the FDA updating its 510(k) database to reflect if the device was the subject of a recall because of a serious design flaw that negatively affected safety or effectiveness and whether the device was cleared on the basis of a predicate recalled for a serious design flaw that negatively affected safety or effectiveness. In these cases, the database entry for such a device should provide a link to information about the predicate’s adverse event reports and recall.