USA – CDRH Works to Develop Proposed De Novo Regulation

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)…