Highlights of FDA's Proposed Rule to Require Unique Identifiers on Medical Devices

Highlights of the proposed rule include:

Standard date formatting. Standardized formatting of dates on medical device labels, eliminating any possibility of confusion from date formats that might be interpreted in more than one way

UDIs required in two forms; direct marking on some devices. Unless the device is excepted, the label of a medical device, and a device package, marketed in the U.S. would be required to bear a UDI; this requirement would be phased in over 5 years, FDA said. The UDI would have to be provided in two forms: easily-readable plain-text and AIDC technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices, such as those that remain in use for extended periods of time and are likely to become separated from their labeling. For each device subject to direct marking, this requirement would take effect two years after the base UDI labeling requirement goes into effect for that device, FDA said.

Device ID and specific production ID required. The UDI would consist of a portion that identifies the specific version or model of the device and the labeler of the device (the device identifier), and a portion that more precisely identifies the specific device by providing variable information, such as the lot or batch, the serial number, expiration date, or date of manufacture (the production identifier), FDA said.

Over-the-counter devices exempt. Devices exempted from this proposed rule include devices, other than prescription devices, that are sold at retail establishments; this exception also applies to such a device when delivered directly to hospitals and other health care facilities, FDA said. Also exempted are class I devices that FDA has by regulation exempted from the good manufacturing practice requirements of 21 CFR 820. The production identifier would not be required for Class I devices.

Requirements apply to combination products, convenience kits, etc. According to FDA, UDI labeling requirements would also apply to: (1) certain combination products; (2) in most instances, to the device constituent parts of combination products; (3) convenience kits; and (4) a device included in a convenience kit, except for a single use device.

Manufacturer responsible in most cases. The labeler of each device would be responsible for meeting labeling and data submission requirements under this proposal. The labeler would, in most instances, be the manufacturer of the device, FDA said.

Device data submitted to FDA for new database. Whenever a device must be labeled with a UDI, the labeler (the person who causes the label to be applied to the device) would have to submit data about that device to the GUDID database, FDA said. This information would have to be submitted no later than the date the label of the device must bear a UDI, and would have to be updated when changes occur. This data would be freely available to the public and would provide the information necessary to identify a device labeled with a UDI.

Effective dates. Proposed effective dates of some provisions include:

• UDI labeling requirements will take effect for class III devices and devices licensed under the Public Health Service Act beginning 1 year after publication of the final rule.
• UDI labeling requirements will take effect for class II devices beginning 3 years after publication of the final rule.
• UDI labeling requirements will take effect for class I devices and devices not classified into class I, II, or III beginning 5 years after publication of the final rule.

(See the FDA’s final rule for details of all proposed requirements and effective dates.)

(See ITT's Online Archives 12070329 for summary of FDA's original announcement of the proposed rule.