For those in the Medical Device Manufacturing industry, and healthcare, this is big news. The FDA’s UDI final ruling was passed on September 24, 2013.
Manufacturers of most medical devices are required to comply. (Exceptions can be found on the FDA’s website.) You will need to get your UDI issued by an FDA-accredited issuing agency.
Today, GS1 Healthcare sent out this announcement:
GS1 received today accreditation by the U.S. Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDIs).
Global GS1 Standards meet the government’s criteria for UDIs and will help manufacturers comply with the requirements of the new FDA UDI regulation, which was published in September 2013 to support patient safety and supply chain security.
The Unique Device Identification system aims at creating a common worldwide system for medical device identification and information that will improve healthcare business processes and patient safety. The US FDA UDI rule is the first to be released but is expected to be followed by other similar regulations worldwide.
Present in 111 countries, GS1 can help manufacturers worldwide to fulfill the requirements of this new regulation.
Visit the FDA UDI website.
Visit the GS1 Healthcare website.
FDA may accredit other issuing agencies in the future. For and updated list, please check the UDI website.
Ready for UDI?
When do you need to get started with your UDI compliance plan? The FDA’s compliance deadlines are assigned by risk classification, but if you are to comply on time, the time to start is now.
If you have to comply with the FDA’s UDI rule and have questions on labeling or direct mark compliance, check out current relevant information on Labeling News. Contact us here or call 603-598-1553 x237 to speak with David Holliday. We will help simplify your UDI compliance.