The American College of Radiology (ACR) submitted comments to the U.S. Food and Drug Administration (FDA) on June 3, 2019, in response to the agency’s discussion paper on artificial intelligence (AI)/machine learning (ML)-based Software as a Medical Device (SaMD).
The agency’s paper addressed a potential framework for regulatory oversight of AI/ML-enabled improvements to SaMD. Certain aspects of the draft proposal would require legislative or regulatory changes.
The ACR’s feedback generally supported manufacturer-developed plans and protocols to be reviewed by the FDA during premarket submissions and additional oversight activities. The comments stressed the need for transparency and engagement of physicians and provider organizations to ensure developer success and the ongoing safety and effectiveness of their products.
The ACR Data Science Institute® guided the development of the comment submission.
For questions about this initiative or other digital health regulatory topics, please contact Michael Peters, ACR director of legislative and regulatory affairs, at (202) 223-1670, ext. 4546 or firstname.lastname@example.org.