The American College of Radiology (ACR) has begun participating in the U.S. Food and Drug Administration's (FDA) Total Product Life Cycle Advisory Program (TAP) pilot.
TAP's goal is to increase radiologist and patient access to safe, effective, and clinically meaningful radiology device innovations, including AI-enabled software. The FDA established it initially to offer input in the areas of patient engagement, clinical evidence development, clinical practice and new technology adoption, and reimbursement and has been limited to certain devices with "Breakthrough Device" designations; it has expanded from solely cardiology devices to neurology, ophthalmology, and radiology devices, the ACR said.
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