USA - May 11 2022
On April 8, 2022, the U.S. Food and Drug Administration (“FDA”) released a draft guidance document titled “Cybersecurity in Medical Devices: Quality…
Edward R. McNicholas, Lauren Sager
USA - January 6 2022
This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on recent developments in FDA inspection policy, including…
Beth P. Weinman
USA - December 3 2021
On November 15, 2021, the U.S. Department of Health and Human Services (“HHS”) and the Food and Drug Administration (“FDA”) issued several policy…
Steven J. Gonzalez, David Peloquin, Beth P. Weinman
USA - November 24 2021
On November 15, 2021, the Centers for Medicare and Medicaid Services (“CMS”) issued a final rule1 implementing, without substantial modification, its…
Thomas N. Bulleit, Austin D. Laroche
USA - November 8 2021
This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on the Biden administration's recent proposal to repeal the Medicare…
Thomas N. Bulleit