The regulatory review pathway for novel devices will receive major policy clarifications by mid-2019, program lead at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) said during a forum at RAPS’ 2018 Regulatory Convergence.
The de novo program—established about 20 years ago as a mechanism to evaluate devices that are by statute automatically classified into Class III—saw an anomaly in 2017 prior to its first user fees, noted Sergio de del Castillo. Last year was a “banner year” with nearly 100 de novo classification requests granted on average, compared to just 22 requests in 2012, when the enactment of FDASIA nixed the requirement on not substantially equivalent determinations.
“There was a mad rush to get in a free de novo at the very end of 2017,” according to de del Castillo. CDRH, however, expects for these average numbers “to steadily increase over time.”
FDA began charging user fees for requested reviews of de novo classification requests last October, following the fourth reauthorization of the Medical Device User Fee Amendments (MDUFA IV).
The agency is now looking to codify the review process and identify required content for de novo classification requests in response to the anticipated program growth, according to de del Castillo.
“We are working to develop a proposed de novo regulation,” de del Castillo added. “There are no de novo[-specific] regulations at this time, which makes it [the de novo program] somewhat of a disadvantage compared to 510(k)s and PMA [premarket applications].”
The new policy clarifications aim to provide manufacturers and FDA review staff with greater consistency. They also speak to a measure of success CDRH set in January to have at least 50% of manufacturers of novel devices come to the US first or in parallel with other markets.
MDUFA IV also added the first performance goals for the de novo program. A manufacturer of a low-risk first-of-its-kind device can choose this option to establish a new classification regulation.
A set of four guidance documents were introduced last year to aid agency review staff meet the MDUFA performance goals for de novos. These include 2017 final guidance
—known as the de novo program guidance—and 2014 draft guidance
on refuse to accept (RTA) policies. These will serve as the primary materials for program development moving forward, said de del Castillo.
The policy clarifications have enabled a more streamlined regulatory review process, as the graphic below on the trend seen in the average time to a de novo MDUFA decision suggests.
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