Credit: Artwell/Adobe Stock
Makers of medical devices that use artificial intelligence are clamoring for clarity from the Food and Drug Administration about its approval framework for devices evolving in real time.
Manufacturers applauded the FDA in April when it issued draft guidance known, in short, as the Predetermined Change Control Plan for AI. A PCCP would allow device makers in the initial premarket submission of a product to essentially prespecify future capabilities of a device without resubmitting it later for approval.
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