Posted by Michael Wonder on 03 Apr 2023
FDA draft guidance allows AI/ML devices to evolve without requiring new submissions
31 March 2023 - The US FDA published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) products can submit pre-determined change control plans in their product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.
