CDRH to Open Digital Health Pre-Cert Program to More Companies by Year’s End

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) said it will expand on its digital health pre-certification pilot program by year’s end.

Between now and December, testing of the first version of the pilot will continue with more participants, though there will still be a lot of unanswered questions as CDRH is “still figuring out how it should look,” Bakul Patel, digital health director at CDRH, said Thursday at the Association for the Advancement for Medical Instrumentation’s (AAMI) conference in Virginia.

Patel said he regrets calling the initial program a pilot because it is better described as a development program co-created with FDA, experts in digital health and other stakeholders.

Last December, CDRH selected nine companies — Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily — to participate in the program by agreeing to provide routine feedback on site visits from agency officials seeking to learn unique approaches to digital health product development.

Yet at the first public workshop, in which the companies and FDA staff briefed participants on the progress made so far, a 10th participant — everyone else — was strongly encouraged to chime in.

There were more questions than answers around the design of the precertification pilot during the January workshop and this is still the case, Michelle Jump, director of cybersecurity regulatory affairs at healthcare solutions providers Carestream, said at the AAMI conference.

The mission is to provide greater flexibility to developers of digital health tools via pre-certifications that would allow them to bypass certain FDA compliance requirements so that there is an added incentive for new digital health products to come to the US market before other countries.

From clinical decision support and telemedicine, to artificial intelligence, cybersecurity, and interoperability, the scope of CDRH’s current definition of digital health is wide-ranging. Yet the products all fall into just four identified categories — software, sensors, technology and connectivity.

Although the pilot is a work in progress, Patel said if FDA expands “the scope too much, we won’t be able to get off the ground,” and that is the real goal. He added that program’s success will be determined by whether there can be a new regulatory paradigm created for the purposes of keeping pace with the iterative nature of digital health products.

Under such a paradigm, the focus will shift to a shared understanding of organizational excellence consisting of best practices for quality digital health development. For the time being, however, CDRH’s work will be targeted at creating a new scheme to help determine regulatory decision-making for exempted products, such as a potentially new 510(k) bar, Patel said.