As the US Food and Drug Administration (FDA) seeks to establish a new regulatory paradigm for digital health products by year’s end, the feedback received from a range of stakeholders on the proposed approach has continued to raise more questions than answers.
Officials at the FDA’s Center for Devices and Radiological (CDRH) have stressed the need for input on the creation of the new program—the Software Precertification Pilot Program—aimed at providing a fast track to the US market for participating digital health developers.
Since last year’s selection of the nine companies required to provide feedback to FDA staff, those that have provided comments have raised several questions in addition to the “challenge questions” outlined in the working model version 0.2
Uncertainty remains around the role of the National Evaluation System for health Technology (NEST), which received an FDA grant in 2016 to establish a real-world evidence safety net, and whether regulating the Pre-Cert program requires additional rulemakings, comments show.
“One potential use of NEST is to generate better evidence for medical device evaluation and regulatory decision-making throughout the device innovation cycle,” Bakul Patel, CDRH associate director for digital health, told Focus
. The goal “at this time” is to launch Pre-Cert version 1.0 by December, which is “within FDA’s current statutory and regulatory authorities in 2019.”
The last comment period closed in June, with 11 submissions posted on the working model version 0.2. These include GE Healthcare and the Clinical Decision Support Coalition (CDS), which expressed concerns over regulatory burden and FDA staffing challenges.
A potential staffing solution GE suggested involves the appointment of an FDA employee as a “scheme manager” to aid in the product review process for a pre-certified firm.
The device manufacturer also questioned a change from the first iteration of the working model in which the second certification level will be made available to all companies, regardless of having any previous experience developing and launching medical devices in the US.
“This very broad leeway, when granted to companies with no track record of designing, developing and maintaining medical devices, introduces unnecessary risk to the program,” wrote Agata Anthony, a regulatory affairs executive at GE Healthcare Digital.
CDS general counsel Bradley Merrill Thompson also raised doubts about the benefits to companies with low-risk products.
“For those products that are ultra-low risk, the calculus is even more tilted toward staying out of the precert program,” Thompson wrote. “For those companies, the Pre-Cert program offers nothing, so the burdens of the program entirely outweigh the benefits.”
Fostering Medical Innovation: A Plan for Digital Health Devices; Software Precertification Pilot Program