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USA - May 11 2022 On April 8, 2022, the U.S. Food and Drug Administration (“FDA”) released a draft guidance document titled “Cybersecurity in Medical Devices: Quality…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