USA – FDA to Test PreCert De Novo Requests Under Pilot

The US Food and Drug Administration (FDA) issued a three-part update Monday on its Pre-Certification (PreCert) pilot program for digital health developers, detailing how the agency intends to operationalize the pilot within its current authorities and test it in 2019 using its de novo regulatory review pathway.

In announcing the updates, FDA Commissioner Scott Gottlieb pointed to two examples of digital health applications that were granted de novo clearances last year. These include’s stroke detection application, which is powered by artificial intelligence, and the two de novo clearances on applications in the new Apple Watch for atrial fibrillation.

The idea for pre-certifying certain digital health developers under the program from FDA’s Center for Devices and Radiological Health and nine selected companies surfaced in 2017. Since then, the plans have drawn more and more scrutiny from industry experts and certain lawmakers. This was partly due to a lack of clarity around how the program would be implemented within FDA’s current statutory authorities as participating companies are allowed to bypass certain premarket requirements.

The four-page report that lays out FDA’s regulatory framework to conduct PreCert within current authorities clarified the use of the de novo classification process for eligible low to moderate risk devices, allowing for the next phase under a scenario limited to software as a medical device (SaMD)…