BOSTON–(BUSINESS WIRE)–#AIautomation–Today, Harrison.ai submitted a Citizen Petition asking the Food and Drug Administration (FDA) to create a streamlined pathway to market for certain AI-powered radiology diagnostic devices. Under the new pathway, manufacturers that have already received 510(k) clearance could comply with robust post-market study requirements instead of submitting new 510(k)s for expanded capabilities. The proposed pathway would reduce delays and costs that restrict U.S. access to AI compared to other nations, with adequate controls to ensure continued safety and effectiveness. Harrison.ai shares the Administration’s interest in ensuring American patients benefit from AI advances in healthcare that are already available in the EU, Asia Pacific, and elsewhere around the world.
While limited to certain radiology products, this proposal could have a substantial effect on promoting AI innovation, as the affected product codes represent ~15% of clearances on FDA’s list of Artificial Intelligence-Enabled Medical Devices. This targeted policy proposal will foster innovation, promote smart regulation that could lower costs for manufacturers, healthcare providers and patients, and facilitate greater access to advanced AI healthcare technology, all while maintaining the US gold standard for safety, effectiveness, and quality.
The new pathway would only be available to manufacturers of computer aided detection and/or diagnosis (CAD) and computer aided triage and notification (CADt) devices with at least one prior FDA 510(k) clearance under a relevant regulation. To be eligible for this “partially exempt” pathway, manufacturers would need to comply with new controls establishing active post-market monitoring, transparency, and mandatory training programs for qualified end users. All current CAD and CADt special controls would still apply. In addition, the partially exempt products would remain Class II medical devices that are subject to all other FDA regulatory oversight. This includes audit, quality management systems, complaint handling, adverse event reporting, recall management, and registration and listing requirements. The existing 510(k) pathway, with no changes to the special controls, will remain available to manufacturers who prefer it.
You can view the full petition here: https://www.regulations.gov/document/FDA-2025-P-5560-0001
About Harrison.ai
Harrison.ai is a global healthcare technology company enhancing clinician capacity and patient care through AI automation. Clinician-led and patient-first, our suite of comprehensive solutions supports earlier, more accurate diagnoses and seamlessly integrate into clinical workflows. Harrison.ai solutions are available in 40+ countries and to half of all Australian radiologists. They are clinically deployed at 1,000+ customer sites globally, including 40+ NHS Trusts. With 3,400+ clinicians using our tools, Harrison.ai has impacted 6.7 million patients’ lives to date. With a growing footprint across the United States, including 8 FDA clearances covering 12 chest x-ray and CT brain indications, 3 FDA Breakthrough Designations, and NTAP reimbursement, Harrison.ai is committed to supporting innovation, quality, and safety for American healthcare.
Visit: Harrison.ai.
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