The American Hospital Association is urging the FDA to revise the current framework for AI-enabled medical device clearance by pursuing risk-based post-deployment standards and other measures.
In a Dec. 1 letter, the AHA said the current framework for medical device oversight does not fully account for risks such as algorithmic bias, hallucinations and model drift. Of the more than 1,240 AI-enabled medical devices approved by the FDA, 96% have been cleared under the 510(k) process.
The association recommended that the FDA update its adverse event reporting mechanisms to capture AI-specific variables, such as model instability or changes in performance between training and real-world populations. It also proposed allowing vendors to submit comprehensive postmarket surveillance plans to streamline future 510(k) applications.
The AHA also urged the FDA to exempt clinical decision support and administrative AI tools from evaluation requirements. Under the 21st Century Cures Act — a 2016 law aimed at accelerating medical innovation — certain software functions, including tools that assist but do not replace clinical decision-making, are excluded from the definition of a medical device.
The AHA also called for interagency collaboration to reduce infrastructure barriers for smaller hospitals and expand access to technical assistance, education and potential grant funding.
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