Under pressure from manufacturers, the FDA is pushing back Unique Device Identification (UDI) compliance deadlines for some non-sterile, class I, and unclassified devices.
Devicemakers will have until September 24, 2020 before they must comply with standard date formatting, labeling and Global Unique Device Identification Database (GUDID) data submission requirements for these devices, according to the new guidance, published in the Federal Register Nov. 5. Manufacturers will also have until Sept. 24, 2022 before they must comply with direct-mark requirements for these devices.
FDA also said it will not enforce the direct-mark requirements for the following categories of devices when each device’s UDI can be derived from other information directly marked on the device:
- class III
- implantable
- life-sustaining
- life-supporting
- non-sterile Class II devices manufactured and labeled before their applicable direct mark compliance date and remain in inventory
- class I and unclassified devices that are nonsterile, manufactured and labeled prior to September 24, 2022 and remain in inventory.
The agency gave manufacturers of non-implantable, non-life-supporting and non-life-sustaining devices that require direct marks and were manufactured and labeled before their label compliance dates another year to meet their direct-marking compliance deadlines. This move was prompted by fears that device-makers would dispose of non-complying inventory rather than undertake costly revisions, a move that could lead to shortages. Devices that were manufactured after their label compliance dates but before their direct-mark compliance dates still must comply with those direct-mark dates.
“The cost of remediating existing devices in inventory to add a direct mark may be substantial, as it can entail different design changes and design validations than those made in order to add a required UDI direct mark to future lots of the device,” the guidance says. “Weighing the benefits and risks, we conclude that this compliance policy for certain inventory devices appropriately serves the public health.”
The UDI regulations have been many years in the making. The FDA published the final rule in 2013 and initially set compliance dates ranging from 2014 through 2020. The new guidance went into effect immediately. A summary can be read here.
