The American College of Radiology® (ACR®) is now participating in the U.S. Food and Drug Administration (FDA) Total Product Life Cycle Advisory Program (TAP) pilot, corresponding with the expansion of the program to include radiology devices. The goal of the collaboration is to increase access for radiologists and their patients to safe, effective and clinically meaningful radiology device innovations, including — but not limited to — certain artificial intelligence (AI)-enabled software devices and other cutting-edge technologies.
The TAP pilot is an engagement program focused on providing innovators of various sizes with strategic input in the areas of patient engagement, clinical evidence development, clinical practice and new technology adoption, and reimbursement. The program is initially limited to certain devices with “Breakthrough Device” designations. It expanded from cardiology device exclusivity to include neurology, ophthalmology and radiology devices.
More information about initiatives to advance radiology AI is on the ACR Data Science Institute® website. For questions about digital health regulatory policy, contact Michael Peters, ACR Senior Director, Government Affairs.