Enforcement of FDA’s Unique Device Identification Law Begins as Hospitals, ASCs, and Nursing Homes Must Now Report Adverse Patient Events from High-Risk Medical Devices
Some clinical laboratory and pathology equipment are Class III (high-risk) medical devices and may be eventually subject to FDA adverse patient event reporting rules
Effective on September 1, 2014, providers using Class III (high-risk) medical devices are required to report adverse patient events involving such devices. That reporting is to include the unique device identification (UDIs) labels of the Class III device.
The primary goal of the new regulation is to have specified providers report patient deaths that involved high-risk medical devices, such as stents and heart valves, for example. Specified facilities include hospitals, ambulatory surgery centers, and nursing homes. Manufacturers must also report adverse patient events involving their Class III medical devices.
All Class III in vitro diagnostic systems used by clinical laboratories and pathology groups here in the United States will now have a UDI label. (more…)