FDA to regulate more AI & software tools as devices, guidance indicates - FDA also seeks new digital health regulatory paradigm in Pre-Cert Program report
Summary
Compared to the September 2019 draft version , the new final guidance notably eliminates FDA’s prior approach of leveraging risk factors to guide the agency’s willingness to exercise enforcement discretion over some categories of products that qualify as medical devices. FDA also recently issued a report on its Digital Health Software Precertification (Pre-Cert) Pilot Program concluding that the approach described in its working model is not practical to implement under current statutory and regulatory authorities. Notably, the September 2019, draft guidance “Clinical Decision Support Software,” updated the framework for FDAs oversight of CDS products, and, among other things, emphasized clarifying how Criterion 4 above applies to machine learning-based and proprietary algorithms. Relatively consistently with the draft guidance, FDA indicates that software functions which apply reviewable reference information or clinical guidelines to patient symptoms/data are not considered medical devices. Nevertheless, the pilot program showed that the “rapidly evolving” digital health technologies “in the modern medical device landscape could benefit from a new regulatory paradigm, which would require a legislative change,” according to the report.