Dive Brief:
- The Food and Drug Administration has given manufacturers of certain Class I and unclassified devices another 75 calendar days to comply with Global Unique Device Identification Database (GUDID) submission requirements.
- In a change implemented without prior public comment, the agency has revealed it will hold off on enforcing the requirements until Dec. 8, 2022. The extension is intended to “help facilitate submission of high quality UDI data to GUDID.”
- The FDA implemented the extension alongside other changes that were discussed in a draft notice last year. Notably, the FDA has finalized its decision not to enforce the GUDID submission requirements on Class I devices it considers to be consumer health products.
Dive Insight:
The FDA published a final rule to establish a UDI system in 2013. Five years later, the agency released draft guidance on the compliance dates for Class I and unclassified devices. Class I devices generally pose the lowest risks. The FDA replaced the initial draft later in 2018 and held a consultation on further planned changes last year, leading to the recent release of final guidance.
After reviewing the feedback, the FDA has gone ahead with plans to exempt Class I devices that are consumer health products from the GUDID submission requirements. The decision reflects the burden of GUDID submission on manufacturers of devices that carry a universal product code, a barcode also known as a UPC, for scanning at the point of sale.
“[The] FDA believes that the entry of UDI data into GUDID, especially given the frequent changes to the UPCs serving as the UDIs for these devices, is burdensome to stakeholders. Further, FDA considered the public health benefit of GUDID submission for consumer health products and the risks to public health if GUDID submission is not provided for these devices,” the agency wrote.
The FDA also pushed through a change to the timeline for non-consumer Class I devices without first consulting with the industry. Previously, the FDA planned to start enforcing the requirements on Class I and unclassified devices starting Sept. 24.
However, the agency acknowledged that the guidance is “being finalized close to that date and that some labelers may have been waiting for the publication of this guidance before planning for GUDID submission,” leading it to grant a 75-day extension.
