Regulatory Affairs

CMS Attempts to Clarify Sunshine Reporting Rules

Devicemakers attempting to comply with the Physician Payment Sunshine Act do not need to report repairs or training provided under warranty or the names of third parties, such as contractors, that indirectly provide a research payment to a doctor or other entity covered under the law, according to the Centers for Medicare & Medicaid Services. Read More

Hong Kong Issues Safety Alert on Sorin Pacemakers

The Sorin Group has sent a Dear Doctor letter to physicians after Hong Kong’s Department of Health received eight reports of faulty elective replacement indicators used to program the settings on three of the company’s pacemakers. Read More