The U.S. Food and Drug Administration (FDA) released draft guidance — — with public comments due July 3.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The 新澳门六合彩官网® (新澳门六合彩官网®) is reviewing the draft guidance. Members interested in providing feedback for potential inclusion in 新澳门六合彩官网’s future comments should contact Michael Peters, 新澳门六合彩官网 Senior Government Affairs Director.