The FDA has a slew of options designed to speed up 510(k) product reviews—be it the relatively new breakthrough device and pre-submission programs, or even the nascent pathways announced last week for safety-focused innovations and certain, well-worn device types—all with the goal of increasing engagement and heading off potential problems earlier in the process.
“Now, that’ll get you maybe down to 90 days—but suppose you would like to have a 510(k) reviewed in two weeks?” posed the agency’s device center director, Jeffrey Shuren. “Well, that requires a different solution.”
Speaking on a panel at the annual MedTech Conference hosted in Boston by industry trade association AdvaMed, Shuren outlined a few of the initiatives the FDA has planned to help accelerate its timelines—by at least a little bit, if 14 days is out of reach—as well as actions manufacturers can take to get their products across the line faster.
More than anything else, it’s a capacity issue, Shuren said.
“It’s an engineering problem. It’s that we receive between three and four thousand 510(k)’s per year—not to mention all the PMAs and supplements and de novos,” he said. “The reviewers have lots of other stuff on their desks.”
And while the industry has, at times, criticized the agency’s efficiency, “the issue is that we can’t expect the FDA to do things faster if we don’t do things better,” said panel member Susan Alpert, principal of SFA Consulting and formerly a senior vice president at Medtronic and director of the FDA’s Office of Device Evaluation. This includes not making full use of the agency’s available program and presenting their product and data in ways reviewers can easily understand.
To better shepherd that flow of submissions, the FDA has mandated the use of templates in 510(k) reviews since late 2015, which steer reviewers building product evaluation memos and provide links to relevant agency guidance documents.
“Now we’re looking at building something similar for industry, on electronic submission templates, to walk them through what to do,” Shuren said.
In the week leading up to the conference, the FDA’s device center published a flurry of guidance documents outlining new, voluntary marketing pathways for specific devices.
They include a proposal modeled after the agency’s Breakthrough Devices Program, geared toward products that offer new innovations in safety—with improvements targeting known adverse events, user errors or other risks—rather than, perhaps, cutting-edge advancements against life-threatening diseases and unmet medical needs. Dubbed the Safer Technologies Program, or STeP, the project aims to offer the same expedited review and benefits afforded to breakthrough devices.
Additionally, the FDA developed sets of its own performance criteria for four types of well-understood devices, which prospective manufacturers can reference in their submissions in lieu of a predicate device. They include conventional foley catheters, skin-based electrodes, spinal plating systems and metallic, non-spinal bone screws and washers.
“Some of the benefits might be the predictability that provides,” said April Veoukas, director of regulatory affairs at Abbott. “It’s an exciting development for the 510(k) program.”
“We can see as these pieces are put out, and as they develop over time, that they do present a lot of opportunity toward the harmonization aspect,” Veoukas said.
There are also lesser-known options for getting direct feedback from FDA reviewers outside of an official regulatory pathway: the agency’s open vendor days and small business fairs, said Maureen Mulvihill, president and CEO of Actuated Medical. Held at the FDA’s campus outside Washington, D.C., these events allow manufacturers to demo their products and answer questions about their design.
“What you get is 15, 20, 50 FDA folks—all coming down for lunch, looking at your technologies and giving their feedback,” Mulvihill said. “Now it’s not a rich event, but it’s good feedback … it’s well worth the time to go down there and just have nice interactions.”
When it comes to submissions, helping reviewers connect the dots in the data and making the information easily searchable is just as important, Shuren said, especially in the move to electronic filings.
“So if you want to be successful with us, one is we have to understand your technology,” Shuren said. “Don't just give us a bunch of schematics, quite frankly—show us the technology. You can do a video. Walk us through it, and let us really understand it. And then, secondly, tell your story.”