DEVICE USER FACILITY CIVIL PENALTIES WILL GO INTO EFFECT
This article was originally published in The Gray Sheet
Executive Summary
DEVICE USER FACILITY CIVIL PENALTIES WILL GO INTO EFFECT after FDA submits a report to Congress stating that there has not been adequate compliance with the user reporting requirements of the Safe Medical Devices Act of 1990. Under SMDA, user facilities are required to report device-related deaths, serious injuries and serious illnesses to FDA and, if known, the device manufacturer.