The U.S. Food and Drug Administration (FDA) has drafted a regulatory framework to test new approaches for the review of digital health device applications.
In 2017, the FDA released its Digital Health Innovation Action Plan, while also unveiling a new precertification pilot program that would soften the regulatory requirements for digital health companies with a track record of developing and testing quality products.
The purpose of FDA’s Software Pre-Cert pilot is to leverage customer input to develop a program that can help reduce the time and cost of market entry for software developers that FDA determines reliably manufacture high-quality, safe and effective digital health devices while providing appropriate patient safeguards, the agency said at the time.
This week, FDA Commissioner Scott Gottlieb, M.D., announced that based on the Pre-Cert pilot, the FDA has drafted a regulatory framework. “Our goal in piloting the Pre-Cert Program was to support the development of new technologies that are frequently updated, as well as to learn from software developers about the unique nature of their products,” Gottlieb stated. “Our aim has been to develop a Pre-Cert program that would allow developers who have been assessed by the FDA for meeting specific excellence principles—known as an ‘Excellence Appraisal’—to participate in a more tailored premarket submission process appropriate for their specific type of digital device.”
Gottlieb noted that FDA’s digital health team has been working with patients, providers, the nine companies participating in the Pre-Cert pilot program and other stakeholders to build this framework. “Today we’re issuing three documents that, together, launch us into the next phase of the agency’s vision of Pre-Cert. These components are a key step in advancing the Pre-Cert model. We look forward to obtaining public input as we implement these elements in the coming months,” he said.
The release of the outline, titled Regulatory Framework for Conducting the Pilot Program within Current Authorities, describes how the agency intends to use its De Novo pathway for novel technologies to implement the next phase of the Pre-Cert pilot, Gottlieb said. This approach, he explained, “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.”
In addition, to further refine how this De Novo process would work for Pre-Cert, Gottlieb said that the FDA needs to test this type of implementation, which is why the agency also released its Pre-Cert Test Plan for 2019. And third, the FDA also released an update to its Working Model that incorporates the Regulatory Framework and Test Plan, and “which will help us understand how well Pre-Cert will work now, but also help us establish the components we envision for the future of Pre-Cert,” Gottlieb said.
