In two new posts on the Covington Digital Health blog we analyze the Digital Health Innovation Action Plan recently released by FDA and the agency’s new software pre-certification (Pre-Cert) pilot program.
The Digital Health Innovation Action Plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and processes and modernizing [the agency’s] tools so that they match the needs of digital health technology, and providing clarity on those policies and processes so that manufacturers and developers know what they need to do.” The action plan includes three action items: (1) issuing new guidance regarding the regulation of digital health, (2) developing new regulatory approaches to oversight of digital health, including a new Pre-Cert program, and (3) building expertise on digital health within the agency.
The Pre-Cert pilot program is the agency’s first step in developing the Pre-Cert program. Under the Pre-Cert program, FDA intends to pre-certify software developers who demonstrate sufficient quality performance. Pre-certified software developers would be able to market their software devices with no, or streamlined, premarket review. The goal of the pilot is to leverage input from the participating companies to help the agency establish the appropriate criteria for pre-certification and appropriate review process for pre-certified companies.