FDA Modernizing 510(k), Other Device Review Processes
Early next year, FDA says it will publish a draft guidance outlining a voluntary, alternative pathway for demonstrating substantial equivalence to meet 510(k) criteria for certain devices. “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,” FDA commissioner Scott Gottlieb says in a 12/11 post.
Under the new framework, device makers could demonstrate substantial equivalence by meeting objective safety and performance criteria, Gottlieb says. These include FDA-recognized standards, guidance documents, or a combination of the two. The pathway would be open 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,” he said. The new approach will also make it easier for the agency to conform its framework for evaluating new products to international consensus standards where such standards exist.
The pathway would be voluntary, and manufacturers could continue to use existing 510(k) pathways. It would apply only to devices where 510(k) clearance is the appropriate route to market and would not affect the current de novo program for more novel devices that do not have a predicate, Gottlieb explained. “But imagine the benefits of a more efficient and transparent pathway for bringing to market well-understood technologies like ultrasound imaging machines, common in vitro diagnostic devices, and blood pressure monitors,” he said.
Another area gearing up for change in 2018 is the post-market follow-up studies FDA may require when allowing a device on the market that has some uncertainty about its probable benefits and risks. “But the balance between acceptable uncertainty in the pre-market setting, relative to a product’s benefits and potential risks — and, in turn, how much reliance FDA can place on post-market follow-up studies — has never been objectively defined in one, comprehensive policy framework,” Gottlieb said in the post.
A separate draft guidance will be issued early next year to outline factors that the agency may consider when assessing acceptable uncertainty, he said. It will discuss how certain issues could be addressed in the post-market setting to allow patients to gain faster access to potentially life-saving devices, when appropriate. “Under this form of more progressive review, FDA will outline how it makes judgments about when it’s appropriate to place greater reliance on post-market data in order to facilitate access to certain innovation, or when the agency needs to rely more on pre-market data collection because of certain issues related to a particular product or how it may be used,” he said. “This balance is already a feature of product review across all of FDA’s programs. The new guidance is an attempt to make these considerations more transparent, consistent, and objectively-defined.”
The factors, according to Gottlieb, will include the extent of the public health need, the seriousness of the illness that the device will treat or diagnose, the size of the population that could benefit from a new innovation, and the benefit-risk profile of alternative therapies or diagnostics. “The likelihood that uncertainty can be resolved by collecting data post-market, such as through the use of registries, is another consideration,” he said. “FDA must have confidence that it’ll be able to acquire required post-market data. This approach to evaluating uncertainty could be used in any one of the existing pathways that developers must follow to market new devices — 510(k), de novo, PMA, or HDE.”
Additionally, Gottlieb said more guidance is forthcoming over the next several months, as outlined in FDA’s list of pending device-related guidance documents listing released 12/11.