FDA to Test PreCert De Novo Requests Under Pilot

Regulatory NewsRegulatory News | 07 January 2019 |  By 

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 Viz.ai’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).

“The validation of the excellence appraisal elements during this testing phase may also provide evidence to develop a framework for a future PreCert model, in which lower-risk products could be introduced directly to market by firms that have successfully been excellence appraised,” the new test plan states.

Under the 2019 test of the PreCert pilot program, the agency intends to use a streamlined approach in conducting a parallel review of a traditional de novo classification request in conjunction with information from sponsors who have undergone an FDA excellence appraisal. This information would take the place of certain content requirements for de novo requests, requirements to establish special controls for reasonable assurance of safety and effectiveness or quality system regulation requirements. 

“The sponsor will incur no additional burden,” Gottlieb said. “Instead, the FDA will set up two parallel review processes, one using the PreCert model and one using the traditional approach to the review of a de novo application.” After a PreCert de novo is granted, pre-certified companies would be directed to submit PreCert 510(k) submissions to propose any new modifications to existing SaMD products under the pilot test.

Challenges have led to delays in opening up PreCert to more companies as CDRH’s previously stated goal was for this to occur sometime between March and December 2018. Still, the agency issued several updates on the development process throughout 2018. The latest updates resulted in the third iteration of the PreCert working model to integrate the new regulatory framework report and the 2019 test plan. 

The PreCert concept also increasingly speaks to placing greater trust on digital health developers with a demonstrated history of meeting an organizational excellence threshold. It also speaks to a CDRH measure of success set in 2018 around attracting manufacturers of novel technologies to the US.

In response to the latest updates, Johnson & Johnson digital health policy lead Diane Johnson told Focus that the company “looks forward to continuing to work with FDA throughout the coming year to develop a process that will facilitate patient access to these products, while ensuring the same regulatory standards for safety and effectiveness are maintained.” Viz.ai CEO and Co-founder Chris Mansi previously told Focus that the company intends to participate once PreCert becomes operational.

Meanwhile, the agency has been prepping for an anticipated spike in submitted de novo requests after a record year in de novo approvals in 2018. The efforts include a new rule—the first one to be de novo-specific—proposed in December 2018 for greater clarity and consistency in de novo requests and review processes.


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