At the beginning of this month (June 2, 2017), FDA has issued a letter to medical device labelers related to adjustments in the compliance deadlines for the Unique Device Identification (UDI) System. 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.
Implementing the UDI system proved to be a significant effort both for manufacturers and for the regulatory authority.
According to the FDA announcement, the decision to postpone was due to ‘complex policy and technical issues’. Both labelers and FDA regulators struggled with answering diverse industry and technology questions. Allocating sufficient resources was also one of the challenges.
The registration of high risk devices already created 1.4 million records in GUDID and we estimate that lower risk devices would generate a comparable number of records. In this context, the decision to postpone the deadline and allow more time for policy clarification and technological updates is welcome. Hopefully, consultations between FDA and industry stakeholders would generate clearer interpretations of the UDI regulations, increasing the quality and standardization of the data recorded in GUDID.
Most manufacturers of low-risk medical devices targeting the US market (especially those with a high volume portfolio) have already started preparing for compliance to the UDI requirements. Now, with the UDI deadline in September 2020, there is more time for adjustments to their quality management system and technical systems to allow for an organized UDI submission process and labeling update.
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 the stage of your UDI implementation, Qserve can be a helpful partner in solving problems and simplifying the compliance process. Do contact us!
Should you want to read more about this subject, I have also written a blog about "EU UDI - new requirements on medical device traceability".