Gregory H. Levine
Ropes & Gray LLP
Articles
Podcast: Non-binding Guidance: FDA Regulatory Developments in AI and Machine Learning
USA - March 4 2021 This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on FDA regulatory developments in the area of artificial intelligence…
Medicare Expands Coverage of “Breakthrough” Medical Devices and Codifies “Reasonable and Necessary” Standard
USA - January 21 2021 On January 14, 2021, the Centers for Medicare and Medicaid Services (“CMS”) published a final rule that significantly alters the Medicare…
New HHS Advisory Opinions Support Broad Application of PREP Act Immunity for COVID-19 Response
USA - November 3 2020 The United States Department of Health and Human Services ("HHS") Office of General Counsel ("OGC") recently issued two advisory opinions (20-03 and…
HHS Prohibits FDA from Requiring Premarket Review of LDTs, Including During the COVID-19 Emergency
USA - August 25 2020 On August 19, 2020, the Department of Health and Human Services ("HHS") published a brief announcement on its website that the Food and Drug…
FDA Issues Final Guidance on Multifunctional Devices
USA - August 19 2020 On July 29, 2020, the U.S. Food and Drug Administration issued final guidance on the regulation of devices with multiple functions, Multiple Function…
