MedTech Dive December 4, 2024
By using pre-determined change control plans, manufacturers can update AI-enabled devices without filing an additional FDA submission.
The Food and Drug Administration issued a much-anticipated update on Tuesday detailing how it plans to regulate changes to artificial intelligence-enabled medical devices after the agency has authorized a product.
The agency shared final guidance on what information it wants to see from manufacturers that propose pre-determined change control plans (PCCPs), a new type of regulatory framework that allows for certain modifications to a device after it is on the market.
The FDA first introduced the concept of PCCPs in a 2019 discussion paper about modifications to AI- or machine learning-based devices. Currently, devices on the market that use AI or machine...
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