The Food & Drug Administration’s proposals to re-vamp its most-used medical device clearance protocol are a mixed bag, according to the agency’s former staff director for the program.
Heather Rosecrans, now a regulatory adviser at the healthcare consulting firm Greenleaf Health LLC, told the audience at the Cooley LLP Medical Device Conference in Boston that she’s skeptical of one new feature in particular: the Centers for Devices and Radiological Health’s proposal to create a new Class IIb designation, which would require clinical data.
"I’m not a proponent of the IIb, personally. 510(k) allows for innovation and flexibility in the process. And what’s new in 510(k) today is old tomorrow, so by the time FDA issues something to put it into a IIb, that can be old tomorrow. I think that will inhibit the flexibility of the 510(k) process itself," Rosencrans said.
In the early 1990s there was a huge backlog of devices at the FDA, Rosecrans said, because the agency didn’t have an adequate scientific staff and lacked the organization to classify devices as they were submitted for clearance. To alleviate the problem the FDA came up with the three-tiered approach to evaluate how rigorous a review process each device needed. About 10 percent required some clinical data, whether 10- or 1,000-patient studies, Rosencrans said.
Over time, however, as clinical data on predicate devices accumulated, some applications were shifted to lower tiers. But maintaining those updates eventually became too cumbersome and time-consuming, according to Rosecrans, adding that she fears the same effect with the Class IIb process.
Other aspects of changes afoot at the federal watchdog are welcome, Rosencrans said, citing portions of the FDA’s push to be more transparent — for example, the decision to publish so-called “de novo” decisions on first-time 510(k) applications, review memos of in vitro diagnostics clearances and impending release of individual 510(k) reviews on the web.
"I really think once those reviews go up, which they’re really pushing to get done, that will serve the purpose of what a formal IIb-type product could be, because you can see what that last 510(k) had,” she said. “I’m hopeful that the auto-review process and summaries will take the place of a IIb process that is more boxed-in."
Rosecrans also had some advice for firms gearing up for submissions.
"The safest thing to do, whether you have a significant- or non-significant-risk device, is to submit pre-[Investigational Device Exemption] and look for that in a 60-day review of what your product is and what you plan on studying," she said, adding that 510(k) is the first step for companies that are as yet unsure if pre-market approval is the way to go.
And, noted Cooley partner and panel moderator Natasha Leskovsek, pre-IDE comments from the FDA can guide the clinical pathway for a device.
"There’s nothing better than getting them directly from the agency," Leskovsek said.
Click here to listen to a free podcast of Rosecrans’ remarks, and the discussion from which they come, during the Cooley LLP Medical Device Conference in Boston; or download an MP3 of the discussion by right-clicking on the link.