Groups tell Congress FDA does not need a new regulatory framework for AI devices
The Advanced Medical Technology Association (AdvaMed) and the America Hospital Association (AHA) told a House lawmaker that the US Food and Drug Administration’s (FDA) existing regulatory framework can accommodate artificial intelligence (AI) in medical devices, including its policies on software as a medical device (SaMD).These groups were responding to a recent request for information from Rep. Ami Bera (D-CA), asking for their input on how AI should be regulated and what controls, if any, were needed to address AI in the healthcare sector. Bera is a member of the bipartisan Task Force on Artificial Intelligence, which was launched in February 2024 to explore whether a new legislative framework is needed for AI. Groups had until 6 May to respond.
The White House also wants Congress to develop AI privacy standards, as stipulated in a October 2023 executive order signed by President Joe Biden.
In March, Bera asked groups to address whether new regulations or policies are needed for AI and whether mechanisms were already in place.
AdvaMed responded that FDA already has a “robust regulatory framework to oversee all medical devices, including AI/ML devices.” The group said that this oversight “is guided by a framework that includes a rigorous premarket review process that assesses medical device performance, reliability, and safety, as well as extensive monitoring and surveillance requirements after devices are authorized for sale. These ensure continued safety and effectiveness throughout the device lifecycle.”
The group noted that AI/ML technology is not new, and that FDA has been reviewing and approving AI applications for “over 25 years.” Further, FDA has already cleared 700 AI-enabled medical devices for a range of uses, including aiding in cancer screening, improving diagnostic accuracy, identifying bone fractures that may not be obvious to human readers, and for detecting coronary artery disease.
AHA agreed with AdvaMed, stating that FDA’s “existing technology-focused regulatory frameworks, such as the guidelines used in the Food and Drug Administration’s (FDA) Software as a Medical Device (SaMD) definitions, provide a solid foundation” for regulating AI.
This framework has been “tested and refined over time” and is “familiar to stakeholders,” said the group, adding that “adapting these frameworks to accommodate the unique aspects of AI could be a more efficient and effective approach than creating new ones from scratch.”
AHA added, however, that it may be necessary in the future for Congress to develop a new framework to accommodate the “rapid development of new AI applications.”
AdvaMed, AHA
