FDA issues draft guidance on UDI
The FDA has released a draft guidance document intended to help medical device labelers and FDA staff understand the FDA's requirements for direct marketing of devices for unique device identificaiton purposes.
“Unique Device Identification: Direct Marking of Devices” explaints that the timeline for UDI compliance varies depending on the class of device. Life-sustaining and life-supporting devices have to have UDI markings by Sept. 24 this year. Class III devices are mandated to comply by Sept. 24, 2016; Class II by 2018 and Class I and unclassified devices by 2020.
Devices already in use have an additional three years to become UDI compliant. The listed deadlines apply to new devices. FDA doesn’t mandate exactly how to mark the devices but suggests that etching or attaching a permanent plaque to durable equipment as possible solutions.
Public comments will be accepted for the next 90 days.
Editor
Editor Beth earned a bachelor’s degree in journalism and master’s in health communication. She has worked in hospital, academic and publishing settings over the past 20 years. Beth joined TriMed in 2005, as editor of CMIO and Clinical Innovation + Technology. When not covering all things related to health IT, she spends time with her husband and three children.