Device chief says FDA could be open to making breakthrough designations public

BOSTON — FDA may be open to making public which devices the agency awards breakthrough […]

BOSTON — FDA may be open to making public which devices the agency awards breakthrough designation, Center for Devices and Radiological Health Director Jeff Shuren said Wednesday at The MedTech Conference, adding he predicts the number of breakthrough devices getting final marketing approval will spike in about a year’s time.
Historically, the agency hasn’t made the breakthrough designations public, “but it would be worthwhile to hear more from companies as to the comfort level on doing that,” Shuren said.

“We have tried to be respectful that we do, in fact, have a number of companies who do not want it to be public yet, just from a competitive standpoint,” he said. “And so we have not put out a list or anything that’s in the public domain if it hasn’t been said by the companies.”

The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Currently, it’s up to the companies participating to make their designation public.
The breakthrough designation positions companies to benefit from additional FDA input as they work to validate the safety and efficacy of their devices, plus an expedited review if the device reaches the approval filing stage. Recent changes to how CMS approaches the reimbursement of devices with breakthrough designations is another potential benefit to companies with breakthrough designations for their devices.
So far, 12 devices that were awarded breakthrough designation have been approved, Shuren said.
That only a dozen breakthrough-designated devices have won final marketing approval so far isn’t “terribly surprising,” Shuren said “because the hallmark of breakthrough is that we try to engage and we engage very early in product development,” he said.
“So, no surprise, you’re going to see a little delay before you start seeing more products on the market.”
But, he said, “I expect in about a year or so you’re going to start seeing this steamroll” of marketing clearances or approvals.
The feedback on the breakthrough program “has been so good, that the number of designations for breakthrough devices has doubled every year for the past few years,” he said. “So this year, and this was just going into the beginning of September — not even the end of the fiscal year —  there were 103 designations.”
That compares to 55 in 2018, 19 in 2017 and 11 in 2016, he said.
“That said, [the program] eats up a lot of resources,” Shuren said. “So we’re going to be monitoring this just to see all the resource implications.”
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