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OIG Issues Unfavorable Opinion on Laboratory Specimen Collection Payments to Hospitals

USA - July 12 2022 The US Department of Health and Human Services Office of Inspector General (OIG) has a long history of skepticism when reviewing financial…

James A. Cannatti III, Tony Maida

Healthcare regulatory check-up newsletter

USA - May 27 2022 This special inaugural issue of McDermott's Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments…

Caroline Reignley, Evelyn (Evie) S. Atwater, Carole M. Becker, Emily Jane Cook, Gregory E. Fosheim, Dexter Golinghorst, James A. Cannatti III, Tony Maida, Adetoro T. Olugbemi, Monica Wallace

AdvaMed Updates Code to Provide Guidance on Innovative Arrangements, Medical Technology, Interactions with HCPs

USA - April 7 2022 The medical device industry has relied on the AdvaMed Code for decades to assist with navigating complex rules concerning compliance—particularly…

James A. Cannatti III, Tony Maida, Anisa Mohanty, Vernessa T. Pollard

FDA Issues Proposed Rule to Amend Medical Device Quality System Regulation

USA - March 1 2022 The US Food and Drug Administration (FDA) published its Medical Devices; Quality System Regulation Amendments proposed rule to amend the medical…

Harrison R. Farmer, Anisa Mohanty, Vernessa T. Pollard

FDA Issues Proposed Rule to Amend Medical Device Quality System Regulation

USA - March 1 2022 The US Food and Drug Administration (FDA) published its Medical Devices; Quality System Regulation Amendments proposed rule to amend the medical…

Harrison R. Farmer, Anisa Mohanty, Vernessa T. Pollard