Will the Final Chapter Come? FDA’s Action Plan for Oversight of Artificial Intelligence/Machine Learning-Based Medical Software


The U.S. Food and Drug Administration (FDA) continues eyeballing evolving medical technology fields such as artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD). In January 2021, FDA issued its Action Plan for how the agency intends to further address its regulation of this area. Although not formal guidance, the document does indicate FDA’s current thinking on the subject and helps clarify what FDA’s next steps will be in the ongoing development of its regulatory framework. While the Action Plan focuses on SaMD, the agency expects some of this work will also be applicable to other medical device areas, including software in a medical device (SiMD). FDA continues to emphasize its collaborative approach to establishing a final regulatory framework and invites stakeholders to proactively provide feedback.

Overall, the Action Plan builds on the foundation FDA previously laid down in its April 2019 Proposed Regulatory Framework for Modifications to AI/ML-Based SaMD (Proposed Framework). Because AI/ML-based SaMD continuously learns, and modifies its algorithms, it would be impractical to solely regulate the technology under FDA’s regulatory framework for SaMD. The general approach FDA has settled on is that pre-market submissions for AI/ML-based SaMD should allow FDA to review and assess the range of modifications to the device that can be expected to result from the AI/ML, and the pre-market submission should also allow FDA to review and assess how such modifications would both stay within that range and occur in a controlled manner.

The Proposed Framework elaborated on this general approach by outlining the following ways FDA intends to approach its regulation of AI/ML-based SaMD:

FDA’s 2021 Action Plan builds on this approach by explaining:

Although FDA’s Action Plan is primarily intended to be deliberative, FDA may incorporate some of the Action Plan concepts into its ongoing reviews of AI/ML-based devices. Beside the agency’s current focus on the commercial AI/ML-based SaMD, FDA may move to address the usage of AI/ML-based SaMD in research, such as its application in drug discovery and development.

The Proposed Framework has a continued interest from Capitol Hill. Most recently, Sen. Bill Cassidy (R-La), who serves on the Senate Health, Education, Labor and Pensions Committee, has asked for the agency’s response before mid-March about its plans for regulating AI/ML-based SaMD, the associated timeline, and the approach to publish guidance. While the agency has said it will rely on the authority already granted to it to move forward, it has also admitted it may need additional mandates from Congress to effectively regulate AI/ML-based SaMD, especially in the context of the 510(k) pathway. Congress and FDA may be able to finalize a fairly comprehensive framework by taking advantage of the ongoing Medical Device User Fee Amendments V negotiations, which will need to be concluded no later than 2022. In other words, 2021 can be an exciting moment for the relevant stakeholders to play an important role to shape the final paradigm.

Because many AI/ML-based SaMD developers are from small academic studios and venture companies; in addition to big technology companies, investors in or the incubators of such technology developers should proactively engage themselves in the applicable rulemaking or legislative process.


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National Law Review, Volumess XI, Number 50