The US Food and Drug Administration (FDA) published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) products can submit predetermined change control plans (PCCP) in their product applications. It has been a priority for industry, which successfully lobbied for the issue as part of last year’s omnibus spending bill.
The draft guidance outlines what the agency needs from AI/ML device sponsors to ensure their change control protocols are safe and well-understood. If approved, manufacturers can update their product without the need to submit a new application or supplement.
While the agency has already allowed more than 500 AI/ML products on the market, many of which already allow PCCP, Congress passed legislation as part of the 2023 Consolidated Appropriations Act that gave FDA explicit authority to approve PCCPs as part of AI/ML product applications…
