April 15, 2021

HHS Rejects Former Secretary 510(k) Exemption Proposals

The Biden Administration announced April 16 its withdrawal of a controversial proposal by the former Secretary of the U.S. Department of Health and Human Services to permanently exempt various class II medical devices from the Food and Drug Administration’s (FDA) 510(k) premarket notification requirements. The exemptions would have included many class II radiology software devices, including artificial intelligence/machine learning (AI/ML)-enabled software for computer-assisted/aided triage, detection, or diagnosis.

In a March 5 letter, the American College of Radiology®, Radiological Society of North America and Society for Imaging Informatics in Medicine urged HHS to reject the proposed exemptions. The organizations cautioned against limiting the FDA’s ability to ensure the safety and effectiveness of the identified radiology software, which would have negative consequences for patients, providers and developers of AI-enabled innovations.

HHS’ April 16 notice concurred with the radiology community. It explained the fundamental flaws with the rationale and data used by the former Secretary to justify the proposal and noted that the FDA itself had not been consulted during development of the proposal.