The Advanced Medical Technology Association (AdvaMed) and the American Hospital Association (AHA) have affirmed that the current regulatory framework of the U.S. Food and Drug Administration (FDA) is well-equipped to manage the integration of artificial intelligence (AI) in medical devices. This response follows a request for information from Representative Ami Bera (D-CA) regarding the regulatory needs for AI in healthcare. Concurrently, the White House has urged Congress to develop AI privacy standards, as outlined in an executive order signed by President Joe Biden in October 2023.
AdvaMed highlighted that the FDA’s existing oversight mechanisms are robust enough to encompass all medical devices, including those with AI and machine learning (ML) capabilities. The organization emphasized that the FDA's regulatory framework includes a comprehensive premarket review process, ensuring medical device performance, reliability, and safety. Additionally, post-market monitoring and surveillance requirements help maintain ongoing safety and effectiveness throughout a device’s lifecycle. The association also noted that AI/ML technology is not a novel concept for the FDA. The agency has been evaluating and approving AI applications for over 25 years. To date, the FDA has cleared approximately 700 AI-enabled medical devices. These devices serve a variety of functions, such as enhancing cancer screening processes, improving diagnostic accuracy, identifying subtle bone fractures, and detecting coronary artery disease.
Echoing AdvaMed’s sentiments, the AHA expressed confidence in the FDA’s technology-focused regulatory frameworks. Specifically, the AHA pointed to the FDA’s guidelines on Software as a Medical Device (SaMD) as a solid foundation for regulating AI. The organization noted that these frameworks have been rigorously tested and refined over time, making them familiar to stakeholders. The AHA suggested that adapting existing frameworks to the unique characteristics of AI could be more efficient and effective than creating entirely new regulatory structures.
However, the AHA also acknowledged the potential need for Congress to develop new frameworks in the future to accommodate the rapid advancement of AI applications. This foresight underscores the importance of ensuring that regulatory mechanisms keep pace with technological innovation to maintain safety and efficacy in the healthcare sector. The FDA, as the federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of medical devices, plays a crucial role in regulating AI technologies. Its established protocols for premarket evaluation, post-market surveillance, and ongoing device performance assessment form the backbone of its regulatory framework. This framework has successfully integrated AI technologies into the healthcare system, demonstrating the FDA’s capacity to manage the evolving landscape of medical innovation.
AdvaMed and AHA have expressed strong support for the FDA’s existing regulatory framework, emphasizing its adequacy in overseeing AI in medical devices. While they recognize the possibility of future adjustments, they advocate for leveraging the current, well-established guidelines to address the unique aspects of AI technology.
