AAIH FDA CDS Comments

This White Paper includes comments to Docket #FDA-2017-D-6569: Clinical Decision to Support Software Draft Guidance.

While we have compiled a combination of general and specific comments, we first want to recognize FDA’s key role in this ecosystem. We applaud the Center for Devices and Radiological Health (CDRH) for its leadership in regulatory policy related to software. We also appreciate the agency’s efforts to clarify jurisdictional lines, including the issuance of this new draft guidance for public comment.

The Alliance for Artificial Intelligence in Healthcare (AAIH) welcomes the opportunity to provide comments on FDA’s Clinical Decision Support Software Draft Guidance issued September 2019. AAIH is an international, not-for-profit, multi-stakeholder advocacy organization (501(c)(4)), launched in 2019 to promote scientific, regulatory, and legislative initiatives necessary to facilitate the development of, access to, and implementation of Artificial Intelligence (AI) powered healthcare solutions.1 AAIH is comprised of over 25 organizations that use or develop AI for biomedical research, development, and clinical applications. Our members include leading-edge start-ups; established pharmaceutical, diagnostics and device manufacturers; academia; and technology and infrastructure developers.

AAIH takes the lead on the sector’s most pressing and significant issues, fostering research, development, investment, and commercialization of transformational medical care for patients worldwide. Our mission is to enable the advancement and use of artificial intelligence in healthcare to improve patients’ lives. As an organization, AAIH is bringing together industry, academia, research institutions, government, NGOs, and other stakeholders to support innovation and the thoughtful and responsible application of AI in the development of new medical interventions. By convening diverse stakeholders with a wide range of relevant expertise and viewpoints, we are working to establish responsible,