Regulatory Editor

The U.S. FDA's emphasis on device safety is well known. Now, the agency has published a draft guidance that aims to provide expedited reviews for device and diagnostic applications that are "reasonably expected to significantly improve" safety, which, in conjunction with the breakthrough devices program, suggests that many other applications will be in the queue for increasingly longer periods of time.

The agency unveiled its medical device safety action plan in late 2018 with several provisions, including a proposal to ban the use of predicates older than 10 years for 510(k) submissions. The latest move, dubbed the Safer Technologies Program (STeP), is voluntary for medical devices, diagnostics and device-led combination products that would prove safer than existing technologies, but also would not qualify for the breakthrough devices program. The scope of the STeP draft includes 510(k), de novo and PMA devices.

The STeP concept is based on the breakthrough devices program. In fact, the FDA said that it would incorporate features into STeP that are part of the breakthrough devices program, such as interactive review. Other features that would migrate over are early engagement on data development plans, prioritized review and engagement by senior managers at the Center for Devices and Radiological Health.

Breakthrough devices, STeP are complementary

The process for STeP commences with a formal request for inclusion via a Q-submission – as is the case with the breakthrough devices program. This would be followed by efforts to expedite the application. With that said, the agency noted that there may be longer review times than would otherwise be the case if the applicant device embodies novel technologies that raise unaddressed scientific questions. The sponsor of a STeP device should "commit to resolving all scientific and regulatory issues" during the review process, according to the draft. With regard to device-led combination products, the draft does not indicate whether the other centers would agree to or be bound by a prioritized review of the component falling under that center's jurisdiction.

The FDA said it will consider proposals for "efficient and flexible" clinical studies, including those employing real-world data sources. However, the device-led combination product might not qualify for STeP unless the device component is identified as providing or contributing to the improved safety profile. Among the device characteristics that would qualify for STeP are a reduced occurrence of either a known serious adverse event or a known device failure mode. Other characteristics that would qualify are a reduced occurrence of a known use-related hazard or an improvement in the safety of another device or medical intervention.

The agency said acceptance into STeP does not necessarily constitute an endorsement of the sponsor's proposed premarket pathway, nor will the agency mandate a particular pathway. Device accessories also would be eligible, and the FDA will accept simultaneous submissions for devices or diagnostics intended to address a given safety consideration. However, an application may be disqualified after entry if the agency determines that the device "is no longer eligible . . . based on available information." The agency is taking comments through Nov. 18, at docket number FDA-2019-D-4048.

'Endless guidance'

Mark DuVal, president of DuVal & Associates PA, of Minneapolis, told BioWorld MedTech that while there are a number of positive elements to take away from the draft, "it would be nice if [the] FDA just did the work of submissions instead of issuing endless guidance documents telling us how they will do the work."

DuVal said that he had spoken with the consultants in his practice, and their view is, "this is yet another FDA program that looks shiny and new, but won't amount to much." He noted that STeP would seem to call on FDA reviewers to work faster and be less risk averse, two features of the process that he said go hand-in-hand. "Our firm feels the pendulum swinging again to the more-difficult-to-work-with end of the spectrum," DuVal said, adding that he and his associates have been "really disappointed in just how difficult young reviewers and branch chiefs can be. And now we are finding office directors have become less likely to overturn their review staffs" than was the case previously.

DuVal noted that positive takeaways from the STeP draft include a focus on getting products to the market more expeditiously and an emphasis on involving senior FDA managers earlier in the premarket review process. The addition of STeP sets up a three-level paradigm of priority, starting with run-of-the-mill devices, STeP devices and breakthrough devices, constituting a regulatory triage of sorts.

The STeP draft suggests that the breakthrough devices program is a success "because it's basically being replicated," DuVal said. However, he noted that there is little objective evidence that the breakthrough devices program has exerted the intended effect. He said former FDA Commissioner Scott Gottlieb claimed that sponsors had filed 110 applications to the breakthrough devices program by the end of 2018, but fewer than 10 of these products have made it to market.

No risk, no reward – no difference?

One of the issues DuVal cited with STeP is that it is not enabled by any change to the statute, so there is no reward for proper administration of the program – and little to no risk for falling short. The program adds more complexity to an already complex task, as well as "a review within a review," he said, adding that the agency "will be asking for even more resources they don't need or deserve to do this program.

"We feel STeP . . . gives [the] FDA a graceful way out of denying a company the breakthrough path," DuVal said, as he asked why this concept calls for a guidance. He went on to note the addition of another source of presubmission interactions likely is to prompt the agency to call for more resources when negotiations commence for the next device user fee program.

DuVal said the White House should consider imposing a moratorium on guidance documents and force the FDA to promulgate regulations. "We are drinking from a fire hose when it comes to FDA guidance, and industry is drowning," he said, adding, "I don't know if it's regulatory fiefdom-building, boredom or both, but they need to take a break on spending precious staff time doing anything but their regular jobs."

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