Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

SEPTEMBER 2, 2022

The Regulations were first issued with immediate effect in 2002 and were later revised in 2016. Good Practice Guide: Membrane Based WFI Systems, May 2002. United States Food and Drug Administration (FDA) – Regulations and Guidances. FDA Proposes Benefit-Risk Considerations for Product Quality Assessments, 20 June 2022.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

FDA 52

FDA Compliance COVID-19 Public Health 52