Medtech manufacturers may soon have clearer guidelines on how to get their products through the FDA’s 510(k) process—with the changes meant to address the widespread criticism of the regulatory pathway in recent years by Congress, consumer advocates, and others.
The FDA’s new final draft guidance, issued July 28, was revised to avoid situations in which risky products such as metal-on-metal hip replacement and vaginal mesh are cleared on the assumption they are similar to other products on the market deemed to be safe. Both of those products cleared via the 510(k) pathway and have resulted in widespread injuries and lawsuits.
In the document, FDA explains that guidance was created “in order to improve the predictability, consistency, and transparency of the 510(k) premarket review process.” The document does so by updating the definition of substantial equivalence, in which devices can be cleared based on similarity to products already for on the market.
In the past, under the 510(k) process, a device firm would claim that a new device is substantially equivalent to another device on the market that was technologically similar—on top of another existing device that had the same intended use. Called “split predicates,” such arguments were a loophole of sorts to the substantial equivalence definition.
But the final draft guidance says: “For a new device to be considered substantially equivalent to a predicate device, the new device must have the same intended use as the predicate device and [FDA’s emphasis] the same technological characteristics or different technological characteristics that do not raise different questions of safety and effectiveness than the predicate device. Therefore, the use of a ‘split predicate’ is inconsistent with the 510(k) regulatory standard.”
The guidance, however, still allows use of multiple predicates to help demonstrate substantial equivalence in certain circumstances, such as when a device such as a patient monitor combines multiple devices, that are each similar to a separate in-use device that also the same intended use.
Manufacturers may also use “reference devices” intended to provide scientific and/or technical information to help address the safety and effectiveness of a new technological characteristic. Reference devices are not predicate devices, and manufacturers may only use them after completing three hurdles in the 510(k) approval process.
The FDA originally entrusted the Institute of Medicine (IOM) with making recommendations on how to approve the pathway. In 2011, the IOM concluded that the 510(k) process was so problematic that it should be eliminated.
The FDA chose to revise the 510(k) pathway instead, ultimately leading to this final guidance document—which is now under a comment period until October 14.
The new guidance also contains new information on special and abbreviated 510(k) programs. FDA promised to finalize those sections later. Manufacturers use the special 510(k) program to modify a previously approved device, and the abbreviated 510(k) program for devices already subject to FDA guidance or standards.
