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See today's BioWorld MedTech
Home » Attorney says PCCPs with change in indication for use not completely impracticable
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Attorney says PCCPs with change in indication for use not completely impracticable

Aug. 16, 2023
By Mark McCarty
The U.S. FDA’s position on predetermined change control protocols (PCCPs) is still in draft form, even though at least one company has won a marketing authorization with a PCCP attached to the underlying artificial intelligence (AI) algorithm. While the agency is still on the fence about a PCCP that incorporates a potential change in the indication for use, regulatory attorney Brigid DeCoursey Bondoc told BioWorld that industry should not reflexively avoid proposing a PCCP with a such change so long as the proposal includes answers to the questions the FDA is sure to ask.
BioWorld MedTech Regulatory U.S. FDA

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