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FDA Updates Guidance on Cybersecurity Responsibilities for Medical Device Manufacturers

USA - May 11 2022 On April 8, 2022, the U.S. Food and Drug Administration (“FDA”) released a draft guidance document titled “Cybersecurity in Medical Devices: Quality…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

Podcast: Non-binding Guidance: Recent Developments in FDA Inspection Policy and Implications for Drug and Device Manufacturers

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

HHS Reverses Course on LDTs: COVID-19 LDTs Again Require FDA Premarket Review

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

CMS Finalizes Repeal of Medicare “Breakthrough” Device Coverage Rule, Pledges to Invite Further Industry Input

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

Podcast: Non-binding Guidance: Rolling Back the Medicare Coverage of Innovative Technology (MCIT) Rule

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