Forbes December 4, 2024
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This week, the FDA issued recommendations for streamlining the clearance process for AI-powered medical devices. The memo announcing this change recognizes that the utilization of AI in devices “is an iterative process” and aims to make it easier to improve software within the regulatory process.
The guidance, which is not legally enforceable but “describe the Agency’s current thinking” suggests that manufacturers could provide a plan for updating AI-powered software in medical devices that would reduce the need to file for a new clearance from the regulatory body. Instead, manufacturers would submit proposed changes to software, a proposal for testing those changes for safety and efficacy and strategies to minimize the risk of updates.
UnitedHealthcare...
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