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Medical Device Manufacturers Could Be Affected by Recent CMS Guidance to Health Care Providers

USA - March 24 2020 Medical device manufacturers, who may already be seeing the effects of lessened demand stemming from a slow-down of elective procedures outside of…

21st Century Cures Act: Key Provisions of Interest to Drug/Device Clients

USA - December 27 2016 On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Cures Act). It is hoped that provisions in the new bill, and the $6…

Nicole J. Aiken-Shaban, Matthew D. Jacobson, Celeste A. Letourneau, Kevin M. Madagan, Vicki J. Morris, Yetunde D. Oni.

MDR Reporting Final Guidance

USA - November 15 2016 FDA issued a final guidance on November 8, 2016, “Medical Device Reporting for Manufacturers”. As with all such guidance documents, it is nonbinding:…

OIG Encourages CMS Claim Forms Which Will Allow For Better Tracking Of Implantable Medical Devices

USA - October 5 2016 On September 30, 2016, the Department of Health and Human Service’s Office of the Inspector General (OIG) issued an “Early Alert” to the Centers for…

Off-Label Promotion And The First Amendment Updates

USA - September 22 2016 Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and…