FDA Issues Draft Predetermined Change Control Plan for Machi

On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial...

Related Keywords

United Kingdom , White House , District Of Columbia , United States , , International Medical Device Regulators Forum , Digital Health Software Precertification Pre , Drug Administration , World Health Organization , Cert Pilot Program , Device Software Functions , European Union , Mcdermott Will , Marketing Submission Recommendations , Predetermined Change Control Plan , Machine Learning , Enabled Device Software , Regulatory Framework , Machine Learning Based Software , Medical Device , Consolidated Appropriations Act , Federal Food , Cosmetic Act , Digital Health Software Precertification , Management Framework , Federal Register ,