Summary
FDA’s January 2021 AI/ML-Based Software as a Medical Device Action Plan identifies five areas of work: a tailored regulatory framework including predetermined change control plans, good machine learning practice, patient-centered transparency, regulatory science on algorithm bias and robustness, and real-world performance monitoring.
Healthcare Implications
Provides historical context for FDA’s subsequent AI-enabled device policy development. Developers and health systems should use the applicable current statutes, regulations and device-specific guidance for present compliance decisions; this action plan describes agency initiatives and does not independently create marketing or postmarket requirements.