FDA lays out plan for improving its regulatory processes

As digital health tools rapidly evolve, the Food and Drug Administration is acknowledging it must modernize its approach to regulation.

The agency, via a new Digital Health Precertification Program, or Pre-Cert, is taking a new look at its oversight of new health tools and policies to become more efficient and promote patient safety throughout the product lifecycle.

“We’ve seen the promise of innovation in products like artificial intelligence software that can help alert physicians to a potential stroke, and smart watches that can help identify atrial fibrillation,” says FDA Commissioner Scott Gottlieb, MD, in a statement to the industry.



Access to robust and timely data, including more extensive and informative post-market data and real-world evidence helps the FDA identify, communicate and act on new or increased medical device safety concerns, he adds.

“Such data serves as the foundation of our commitment to improving our nation’s post-market medical device surveillance. Today, we’re announcing that based on the Pre-Cert pilot, we’ve drafted a regulatory framework to test new approaches for the review of digital health device applications.”

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Consequently, FDA has unveiled a program under which developers with a track record of a culture of quality and organization excellence, under Pre-Cert can have a more tailored premarket submission process appropriate for their specific device for which they seek FDA approval.

FDA already has its De Novo pathway program to streamline marketing approval for low and moderate risk devices. In the Pre-Cert program, quality requirements would be satisfied by information the FDA collects through the Excellence Appraisal process.

“By collecting this information early, the Excellence Appraisal could be leveraged to streamline a developer’s De Novo pathway since the information would already have been demonstrated and documented during the Excellence Appraisal,” Gottlieb explains. “This allows the FDA to tailor the premarket submission content to the unique considerations related to each particular digital health device and enables more efficient evaluation of low-risk digital health devices.”

During 2019, the agency will test the pilot program to see how well Pre-Cert can maintain standards for safe and effective products by comparing the traditional reviews against the De Novo process.

Already, however, the FDA appears to already have decided it is on the right track. “At the conclusion of the testing and refinement, we expect to have confirmed that the evidence collected through the proposed Excellence Appraisal and streamlined De Novo submission meets the statutory requirements for granting marketing authorization.”

The complete statement from Gottlieb is available here.