Harrison.ai Submits FDA Petition to Streamline Access to Radiology Innovations
TECHNOLOGYHEALTH & BEAUTY
Harrison.ai has 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.
The potential for Artificial Intelligence (AI) to revolutionize medical diagnostics, particularly in radiology, is immense, but regulatory bottlenecks often slow its adoption in the United States. In a move designed to accelerate innovation while maintaining the highest safety standards, global healthcare technology company Harrison.ai has formally submitted a Citizen Petition asking the Food and Drug Administration (FDA) to establish a streamlined market pathway for certain AI-powered radiology devices.
The proposal targets specific AI products already proven safe and effective, aiming to increase U.S. patient access to advanced diagnostics that are currently available in the EU, Asia Pacific, and other parts of the world.
The Problem: Slowing Down Progress
Currently, even minor expanded capabilities in AI diagnostic tools require manufacturers who have already achieved an initial FDA clearance (typically 510(k)) to submit an entirely new clearance petition. This lengthy and costly process can delay the introduction of enhanced, more accurate AI features.
Harrison.ai’s proposal seeks to address this by creating a “partially exempt” pathway for manufacturers of specific computer-aided detection and diagnosis (CAD) and computer-aided triage and notification (CADt) devices. These product codes represent approximately 15% of all AI-enabled medical devices on the FDA's list, meaning the change could have a substantial effect on the market.
Under the new pathway, manufacturers who have already secured their initial 510(k) clearance could bypass the need for a new clearance for expanded capabilities, provided they comply with a robust set of new post-market requirements.
Safety First: Maintaining the Gold Standard
Crucially, this proposal does not suggest lowering the bar for patient safety. Harrison.ai’s framework is built on ensuring that innovation happens within strict, transparent, and enforceable regulatory controls.
To be eligible for the "partially exempt" pathway, manufacturers would be required to implement new controls emphasizing:
Active Post-Market Monitoring: Continuous tracking to ensure ongoing safety and effectiveness.
Transparency: Clear communication regarding device updates and performance.
Mandatory Training Programs: Ensuring qualified end-users are properly trained on the technology.
Furthermore, the affected products would remain classified as Class II medical devices, subjecting them to full FDA regulatory oversight, including audits, quality management systems, complaint handling, and adverse event reporting. The existing, full 510(k) pathway would also remain available to manufacturers who prefer it.
As a company with a growing U.S. footprint, including eight FDA clearances and three FDA Breakthrough Designations, Harrison.ai is invested in both quality and innovation.
By proposing smart, targeted regulation, the company hopes to lower costs for manufacturers and healthcare providers while facilitating greater, faster access to advanced AI for American patients, upholding the "US gold standard for safety, effectiveness, and quality" while accelerating technological progress.