Several dates for UDI compliance have been postponed:
• Class I and unclassified devices – 24th of September, 2020
• Direct Marking of Class I and unclassified devices – 24th of September 2022
Low-risk devices are required to follow the UDI ruling two years later than it was originally planned (24th of September 2018). Class I GMP exempt devices are not required to comply with UDI requirements. Higher risk devices (Class II, Class III and implantable and life-supporting or life-sustaining devices) must already be in compliance with the UDI provisions, both for labeling and GUDID data submission requirements.
In case you would like to know more on the topic, here are the links to the FDA letter and general UDI deadlines. Did you already start addressing UDI requirements? If not, it is best to plan ahead and avoid surprises, do not leave compliance issues for the last minute.
Whatever stage of your UDI Implementation, Pragmatyxs can be a helpful partner in creating solutions and simplifying the compliance process.