FDA 2.0: Initial upgrade complete — federal legislative action is necessary to regulate Dr. Robot
Summary
As artificial intelligence and machine learning advance, medical devices will detect disease earlier, diagnose more accurately, target better therapies and improve personalized medicine. After five years of collecting data from nine volunteer companies considered to be the leading developers of digital health products, the FDA issued a final report — "The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings," Sept. 26, 2022 — discussing the results of its revolutionary Pre-Cert Program, which concluded that rapidly evolving medical device software technologies could benefit from an updated regulatory framework. Most importantly, the Cures Act provides that devices classified as low-risk medical software that serve as electronic patient records or data storage are to be excluded from the lengthy premarket review process. An overview of the pre-cert pilot program The FDA launched the Pilot Program as an initial step forward in developing a new regulatory framework that accommodates the distinctive nature of Software as a Medical Device (SaMD) and replaces the FDAs current product-by-product premarket review process with a "pre-certify" process for SaMD developers who demonstrate sufficient quality performance. Abbye E. Alexander and Christopher J. Tellner are regular, joint contributing columnists on health care litigation for Reuters Legal News and Westlaw Today.