Since 1995, the agency has approved 950 AI- and machine learning-enabled medical devices. The new guideline, drafted in early 2023, provides recommendations for device manufacturers planning to upgrade already approved products with AI without needing to file another marketing submission.
Manufacturers planning to modify their products over time are advised to include a detailed description of modifications, a modification protocol and an impact assessment. They should also consider the intended use populations and environments of use, the FDA guidance said.
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