FDA: Artificial Intelligence & Medical Products

Released: March 15, 2024

Background

The Food and Drug Administration (FDA) is tasked with reviewing medical devices for approval and use within healthcare. Three of the main avenues the FDA utilizes to review and approve medical devices is premarket 510k clearance, De Novo classification, and premarket approval. Approval authorities also include the ability for the FDA to review and clear modifications to medical devices, including software as a medical device.

Currently, the FDA has stated it does not believe the current paradigm of medical device regulation was designed for adaptive artificial intelligence and machine learning technologies.¹ The FDA has stated 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) within the FDA are working in tandem on a review and approval framework that encompasses AI innovations. As part of the FDA’s efforts to clarify how they are approaching AI oversight through their existing authority, the agency released a paper titled, “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” detailing how the agency will “collaborate to protect public health while fostering responsible and ethical medical product innovation through AI.”

Overview

The paper describes four areas of focus for CBER, CDER, CDRH, and OCP when it comes to evaluating AI within medical products. The areas of focus include:

• Fostering collaboration to safeguard public health;
• Advancing the development of regulatory approaches that support innovation;
• Promoting the development of harmonized standards, guidelines, best practices, and tools; and
• Supporting research related to the evaluation and monitoring of AI performance.

One of the key aims of the FDA is to build regulatory approaches that can be applied across different types of products the FDA reviews. With the FDA limited in its regulatory authority to fully regulate AI, the agency has outlined several actions organized around the four focus areas. These actions include:

• Fostering collaboration to safeguard public health through continued work with developers, patient groups, academia, global regulations, and other interested parties;
• Advancing the development of predictable and clear regulatory approaches that support innovation in the use of AI;
• Promoting the development of standards, guidelines, best practices, and tools for the medical product lifecycle that build on Good Machine Learning Practice Guiding Principles²; and
• Supporting research related to the evaluation and monitoring of AI performance through demonstration projects and activities that gain insight into AI’s impact on medical product safety and effectiveness.

The FDA has reiterated its commitment to working through its regulatory pathways to ensure AI under the agency’s purview complies with existing standards. Like many HHS agencies, the paper highlights the FDA’s interest in the development and use of standards in AI development and indicates the FDA will continue to adjust its approach to the rapid development of AI and the continual need for regulatory adjustments.

¹ Available at: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device.

² Available at: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles.