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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…

Kellie B. Combs, Sarah F. Blankstein.

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…

Mara Sanders, Thomas N. Bulleit, William Hudson.

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…

David Peloquin, Joshua Oyster.

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…

Beth P. Weinman.

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…