New FDA guidelines for 510k could be big win for ARCH.
Yet despite manufacturers being able to demonstrate that they meet these consensus standards, a manufacturer is required to demonstrate that a device is substantially equivalent to an existing, legally marketed device. But the predicate devices that new products must compare themselves to are sometimes 40 years old. FDA recognizes that such direct comparison testing creates burdens for 510(k) applicants, especially when many new devices are designed in novel ways, using more advanced technologies. It’s sometimes hard to identify sufficient, appropriate predicate devices in order to conduct testing. This can create an obstacle to certain kinds of innovation and lead to inefficiency in the review process with few, if any, benefits to patient safety. In fact, at times, it can make it less efficient for FDA to assure the safety of the device.
New Steps to Reform, Modernize 510(k) Review
To address these challenges, in the first quarter of 2018, FDA intends to publish a draft guidance outlining a voluntary, alternative pathway for demonstrating substantial equivalence. This pathway will allow more flexibility to use more modern criteria as the reference standard, and permit comparisons to standards that more closely approximate the kind of novel technology we’re being asked to evaluate.
Under this new framework, device manufacturers could demonstrate substantial equivalence by meeting objective safety and performance criteria. These can include FDA-recognized standards, FDA-developed guidance documents, or a combination of the two, which embody the safety and performance criteria that new devices could meet to be cleared under a 510(k). This pathway would be available for pre-specified categories of mature devices – those for which safety and performance criteria that meet or exceed the performance of existing, legally-marketed devices can be identified. It will be outlined in new draft guidance that we are announcing today in the Federal Register and plan to issue in the first quarter of 2018. This approach will also make it easier for FDA to conform its framework for evaluating new products to international consensus standards where such standards exist.
The program will be voluntary, and manufacturers could continue to utilize the existing 510(k) pathways. It would apply only to devices for which 510(k) clearance is the appropriate pathway to market
