FDA drafts pathway for digital health innovations

The FDA announced that it has drafted a regulatory framework to test new approaches for the review of digital health device applications. The framework is based on the Digital Health Precertification (Pre-Cert) programme that was piloted after the agency announced its Digital Health Innovation Action Plan in 2017. "The plans we're launching today demonstrate our ongoing commitment to building a Pre-Cert programme that recognises the unique and iterative characteristics of digital health products, as well as their significant potential to improve the lives of patients," stated FDA Commissioner Scott Gottlieb.

One of the documents unveiled by the FDA, titled Regulatory Framework for Conducting the Pilot Programme within Current Authorities, aims to clarify how the agency intends to use its De Novo pathway for novel technologies to implement the next phase of the Pre-Cert pilot. According to Gottlieb, the De Novo pathway is "well-suited" to meet the goals of Pre-Cert as it is a pathway for certain novel types of low- to moderate-risk devices to obtain marketing authorisation. He indicated that this approach "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."

Specifically, in the Pre-Cert pilot, many of the "quality system regulation" requirements that already have to be met by companies submitting products for review under De Novo, would be satisfied using information collected during the agency's "Excellence Appraisal" process, which is aimed at evaluating the quality and excellence of the software developer for Pre-Cert. By collecting this information early, Gottlieb said the Excellence Appraisal could help streamline a developer's De Novo filing, "reducing content the developer would need to submit to the agency...since the information would already have been demonstrated and documented during the Excellence Appraisal."

The agency also released its Pre-Cert Test Plan for 2019 to further refine how the De Novo process would work for Pre-Cert. Gottlieb explained that the FDA will test its pilot programme to determine how standards for quality and safety assurance can be maintained under Pre-Cert and assess how the Pre-Cert model compares with the agency's traditional submission pathway.

Finally, the FDA unveiled an update to its Working Model that incorporates the Regulatory Framework and Test Plan to "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." The Pre-Cert model begins with appraising the excellence of the firm and reviewing related documentation, followed by a review of the streamlined Pre-Cert De Novo request submission, which would include a manufacturer's plan to monitor and evaluate the real-world performance of the software. "Proactive monitoring of real-world performance enhances an understanding of how the software continues to perform while in use, while helping the developer and the FDA to quickly identify and address potential safety issues along with additional benefits to patients," Gottlieb said.

According to the Commissioner, "our new actions will promote the development of novel, beneficial technology while ensuring that patients have access to high quality, safe and effective digital health devices."