[Video] The future of the UDI rollout
by Laura Johnson, on March 9, 2016
New provisions of the FDA's UDI regulations will be going into effect in September 2016. But that doesn't mark the end of the work that medical device manufacturers will have to do to ensure compliance.
The UDI was designed to phase in slowly, finally reaching full implementation by 2020. There will be two more UDI compliance deadlines to go following the upcoming one this year. In September 2018, reusable Class II medical devices will require a permanent UDI label, and the same will apply to the packages of Class I devices. By September 2020, all reusable devices must bear permanent labels.
This process was designed to give manufacturers plenty of time to create labels that comply with the FDA's rules and can be stored in the agency's database. Loftware's Enterprise Labeling can help by delivering an end-to-end supply chain labeling solution that supports the specific needs of the medical device industry.
For more information on medical device labeling and UDI requirements, download the on demand webinar below.