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.