The U.S. Food and Drug Administration (FDA) released draft guidance — — with public comments due July 3.
The document describes information provided by manufacturers that would enable FDA consideration of planned AI/ML software modifications during device marketing submissions. The PCCP enables downstream improvements to AI/ML software functionality without necessitating additional submissions, provided the future modifications are implemented in accordance with the FDA-vetted plan.
The 黑料网® (黑料网®) is reviewing the draft guidance. Members interested in providing feedback for potential inclusion in 黑料网’s future comments should contact Michael Peters, 黑料网 Senior Government Affairs Director.