Radiology Groups Push HHS to Reject Proposal for Permanent De-Regulation of AI Software

U.S. Department of Health & Human Services (HHS) officials should reject a last-minute proposal to permanently exempt certain medical devices, including several used by radiologists, from Food & Drug Administration (FDA) 510(k) premarket notification on requirements, said several industry leadership groups.

In a March 5 letter to the HHS, leaders from the American College of Radiology (ACR), Radiological Society of North America (RSNA), and the Society for Imaging Informatics in Medicine (SIIM) urged department officials to forego the recommendation from immediate-past HHS Secretary Alex M. Azar, II.

This proposal would permanently exempt multiple devices, including artificial intelligence/machine learning (AI/ML)-enabled software for computer-assisted/aided triage, detection, or diagnosis, from the FDA 510(k) permanent review.

“This proposal is extraordinarily concerning from a patient safety perspective. Although we do not anticipate implementation by the current administration, informatics experts must inform regulators of the potentially harmful impacts resulting from this idea in case the proposal resurfaces,” said Howard B. Fleishon, M.D., MMM, FACR, chair of the ACR Board of Chancellors, noting the proposal contradicts the agency’s previously-stated plans for improving oversight of AI/ML-enabled software.

Specifically, this proposal would exempt both chest X-ray and lung CT CAD, CAD software for fracture and lesions suspicious of cancer, X-ray angiographic imaging-based coronary vascular simulation software devices, automated radiological image processing software, and AI-guided image acquisition or optimization.

Even though the FDA has already cleared several AI/ML-enabled devices for use in radiology, oversight challenges from changing practice environments, diverse patient populations, and input devices still linger. Consequently, this proposal is problematic for two reasons, organization leaders said. Not only does the recommendation offer no alternative to 510(k) requirements that could ensure exempted products perform safely and as intended once installed, but it could also open the door for a gap in oversight and could be counterproductive to the FDA’s responsibility in the AI imaging market.

Instead of allowing this breakdown, said ACR Data Science Institute Chief Medical Officer Bibb Allen, Jr., MD, FACR, pressed the FDA to make safety and effectiveness a priority. Additionally, Christoph Wald, M.D., Ph.D., MBA, FACR, chair of the ACR Commission on Informatics, said the FDA should strengthen its ability to ensure correct algorithm performance through multi-site validation, post-market monitoring of longitudinal performance, and other measures.

“Our organization strongly recommends that HHS and FDA not implement broad and permanent exemptions from 510(k) pre-market notification requirements for identified class II radiology devices,” organization leaders wrote in their letter. “We urge FDA to continue collaborations with the healthcare provider community to enhance clinical validation and real-world monitoring of AI/ML-enabled radiology software to ensure safety and effectiveness, and ultimately help establish trustworthiness and promote clinical adoption of promising innovations.”

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