In September 2022, the U.S. Food & Drug Administration (FDA) released its Clinical Decision Support (CDS) Software Guidance and the final report on the Software Pre-Certification Pilot Program. The new FDA policies move away from prized flexibilities in the previous guidelines governing software products. In the new and final CDS Guidance, FDA modified its interpretation of each of the four criteria in section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act, significantly narrowing what FDA considers exempt from regulatory authority. FDA also released its report, Digital Health Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings, detailing the results of the pilot program and ultimately shutting down the initiative. FDA originally envisioned the precertification program as a way to adapt regulatory processes originally intended for hardware medical devices to match the faster pace of development and update cycles of software as a medical device, particularly artificial intelligence and machine learning functions. Although FDA reported that the pilot provided key insights and a better understanding of the concepts in the proposed program, it concluded that it lacked statutory authority for the program and that implementing it “would require a legislative change.” At year end, best practices, materials, and potential product risks in the digital health industry are still novel concepts. To ensure successful continued development of these products, medical device manufacturers will need to stay up to date on the evolving standards in this space as we enter 2023.
This post is a part of a series on trends in the artificial intelligence space for 2023, authored by MoFo lawyers.