Latest FDA Guidance on Medical Device AI

The impact of Artificial Intelligence (“AI”) is being seen throughout society, and the medical device community is no exception. Regulatory bodies have taken notice of the tremendous benefits offered by AI-based medical devices in advancing product development and improving patient care while at the same time recognizing the additional complexities and the resulting need for guidance and regulation. In fact, in March of 2024, the European Union approved the Artificial Intelligence Act, which represents the first comprehensive legal framework regulating AI in the European Union (Artificial Intelligence Act - What You Need to Know). Here in the U.S., the FDA has also responded with the release of new guidance titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together”.

The FDA’s new guidance document was jointly published by the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination Products (OCP). The document stipulates four areas of focus regarding the development and use of AI across the medical product life cycle, as well as corresponding actions to be taken by the FDA:

Foster Collaboration to Safeguard Public Health

1. Solicit input from a range of interested parties to consider critical aspects of AI use in medical products, such as transparency, explainability, governance, bias, cybersecurity, and quality assurance.

   
   

2. Promote the development of educational initiatives to support regulatory bodies, health care professionals, patients, researchers, and industry as they navigate the safe and responsible use of AI in medical product development and in medical products.

   
   

3. Continue to work closely with global collaborators to promote international cooperation on standards, guidelines, and best practices to encourage consistency and convergence in the use and evaluation of AI across the medical product landscape.

   
   

Advance the Development of Regulatory Approaches That Support Innovation

1. Continuing to monitor and evaluate trends and emerging issues to detect potential knowledge gaps and opportunities, including in regulatory submissions, allowing for timely adaptations that provide clarity for the use of AI in the medical product life cycle.

   
   

2. Supporting regulatory science efforts to develop methodology for evaluating AI algorithms, identifying and mitigating bias, and ensuring the robustness and resilience of AI algorithms to withstand changing clinical inputs and conditions.

   
   

3. Leveraging and continuing to build upon existing initiatives for the evaluation and regulation of AI use in medical products and in medical product development, including in manufacturing.

   
   

4. Issuing guidance regarding the use of AI in medical product development and in medical products.

   
   

Promote the Development of Standards, Guidelines, Best Practices, and Tools for the Medical Product Life Cycle

1. Continue to refine and develop considerations for evaluating the safe, responsible, and ethical use of AI in the medical product life cycle (e.g., provides adequate transparency and addresses safety and cybersecurity concerns).

   
   

2. Identify and promote best practices for long-term safety and real-world performance monitoring of AI-enabled medical products.

   
   

3. Explore best practices for documenting and ensuring that data used to train and test AI models are fit for use, including adequately representing the target population.

   
   

4. Develop a framework and strategy for quality assurance of AI-enabled tools or systems used in the medical product life cycle, emphasizing continued monitoring and mitigation of risks.

   
   

Support Research Related to the Evaluation and Monitoring of AI Performance

1. Identify projects that highlight different points where bias can be introduced in the AI development life cycle and how it can be addressed, including through risk management.

   
   

2. Support projects that consider health inequities associated with the use of AI in medical product development to promote equity and ensure data representativeness, leveraging ongoing diversity, equity, and inclusion efforts.

   
   

3. Support the ongoing monitoring of AI tools in medical product development within demonstration projects to ensure adherence to standards and maintain performance and reliability throughout their life cycle.

   
   

The FDA will continue to tailor its regulatory approaches to the specific issues inherent in AI-based medical devices. As AI continues to evolve and expand, medical device manufacturers are urged to stay close to additional announcements and actions from the FDA and other regulatory bodies and ensure a thorough understanding of the impact on their respective organizations.

If you need any guidance with respect to AI-based medical devices, or if you need assistance with any other regulatory or quality-related issues for your medical devices, please contact PRP.