On January 12, 2021, the U.S. Food and Drug Administration (FDA) published its Action Plan for further development of the Agency’s framework for regulatory oversight of artificial intelligence (AI) and machine learning (ML) based Software as a Medical Device (SaMD). The Action Plan identifies several opportunities for SaMD developers to engage the FDA as its regulatory framework for AI/ML-based SaMD oversight evolves:
- Predetermined Change Control Plans: FDA remains committed to refining a regulatory framework that would allow for some post-market SaMD modifications based largely on the establishment and utilization of SaMD Pre-Specifications (SPS) and an Algorithm Change Protocol (ACP) set forth in a “Predetermined Change Control Plan.” SaMD developers can expect, and be ready to submit comments on, a draft guidance in 2021 addressing a Predetermined Change Control Plan.
- Real-World Performance: Real-world data collection and monitoring is another key concept in FDA’s proposed regulatory framework for oversight of modifications to AI/ML-based SaMD. FDA plans to advance real-world performance monitoring pilots with stakeholders on a voluntary basis, and use the learnings from these activities to develop a framework for gathering and validating relevant real-world performance parameters and metrics.
- Algorithm Transparency: To identify types of information that FDA may recommend SaMD developers include in the labeling of their AI/ML-based devices, FDA intends to hold a public workshop to elicit input from the broader community on how device labeling supports transparency to users.
FDA also will continue to participate in global working groups focused on harmonizing principles of Good Machine Learning Practice (GMLP) as well as expand upon the Agency’s efforts to develop methods for evaluating and addressing algorithmic bias.
The Agency recognizes that continued stakeholder engagement will be crucial for the formation of a sensible regulatory framework for oversight of AI/ML-based SaMD. SaMD developers seeking to inform the development of FDA’s regulatory framework are strongly encouraged to participate in the specific opportunities outlined in the Action Plan.