FDAnews Device Daily Bulletin

Proposed Sunshine Act provisions for documenting devicemaker payments to physicians need more context and clarity, industry members say. Simply posting dollar amounts paid in consulting arrangements could be misleading because the public may not be aware of the length or intensity of required clinical trials, Medtronic Vice President Thomas Schumacher said in comments on the Centers for Medicare & Medicaid Services (CMS) proposed rule to implement the Physician Payment Sunshine Act, a provision of the 2010 Affordable Care Act. The public comment period closed Feb. 17.
Devices & Diagnostics Letter