AHA Comments on FDA Guidance on Clinical Decision Support Software

The AHA commented on the Food and Drug Administration’s draft guidance for industry and FDA staff on clinical decision support software as part of the agency’s efforts to implement Section 3060(a) of the 21st Century Cures Act. AHA expressed concern that “FDA’s interpretation of certain criteria could result in many existing CDS algorithms being subject to the FDA approval process and ultimately slow the pace of innovation and development of new algorithms to support better patient care and outcomes.” In its letter, AHA shared specific recommendations with FDA and said it “looks forward to working with the FDA to ensure the agency’s regulatory approach to implementing Section 3060(a) is consistent with the language and intent of the Cures Act and prioritizes patient safety while at the same time allowing hospitals and health systems to continue to implement innovative decision support tools.”

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