The FDA's first comprehensive draft guidance on AI-enabled device software asks manufacturers to manage these products across the total product lifecycle, including performance monitoring after deployment and Predetermined Change Control Plans that define how a model may change without a new submission. The signal for health systems: the agency now treats a cleared model as a starting point, not a finished product. Governance leads should expect to mirror that expectation internally, tracking whether a vendor's cleared tool still performs the way it did the day it was approved. As one analysis noted, AI bias can produce erroneous results in a systemic but unpredictable way. The comment period closed in April 2025; the direction of travel is set.
Regulatory
FDA wants AI devices watched for their whole life, not just at clearance
FDA draft guidance asks manufacturers to monitor AI-enabled devices across their whole lifecycle, not just at clearance.
CHARGE and Grid Health
CHARGE publishes independently. Grid Health, built in response to its members, runs the AI operations center health systems use to monitor models, detect drift, and govern AI in production.
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