The FDA joined the ACR® Data Science Summit June 9, during the Society for Imaging Informatics in Medicine annual meeting. FDA officials provided an update about their Total Product Life Cycle Advisory Program (TAP), which expanded to radiology devices in October 2024 in partnership with ACR.
TAP helps innovators of eligible breakthrough devices connect early with providers, payers and patient advocates. These engagements with ACR and others address clinical use and adoption considerations beyond FDA authorization.
Officials also highlighted a recently announced joint FDA/CMS initiative. The initiative, the proposed Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, would allow evidence generated for FDA review of eligible devices to also support expedited Medicare coverage decisions. Details of RAPID have not been released but are expected in the coming months.
Learn more about ACR’s radiology AI initiatives at the ACR Data Science Institute®. For questions about FDA policies and programs, contact Michael Peters, ACR Senior Director, Government Affairs.
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