On Friday, FDA released a final rule implementing a “unique device identifier” (UDI) system. The final rule retains the basic framework and most of the key requirements of the proposed rule. (For a summary of the proposed rule, see our July 16, 2012 client alert.) Nevertheless, the final rule contains several important differences from the proposed rule, as outlined below.
As background, section 519(f) of the Federal Food, Drug, and Cosmetic Act directs FDA to issue regulations for a UDI system requiring the label of devices to bear a unique identifier that adequately identifies the device through distribution and use. Last year’s FDA Safety and Innovation Act amended section 519(f) to require FDA to issue proposed regulations establishing a UDI system by December 31, 2012, and a final regulation no later than six months after the close of the comment period on the proposed rule. FDA met the first, but not the second, of these two deadlines. FDA also is required to implement the final regulations with respect to devices that are implantable, life-saving, and life-sustaining no later than two years after the regulations are finalized.
While retaining many of the key elements of the proposed rule, the final rule reflects several significant changes:
- The final rule allows FDA to grant a case-by-case extension of the one-year compliance date for class III devices to comply with certain requirements of the rule.
- Devices manufactured and labeled before the compliance date for that device are exempted from the rule for an additional three years after the compliance date. In other words, manufacturers will have three years after the compliance date to exhaust existing inventories without needing to re-label those devices.
- Device constituents of combination products and convenience kits are exempted from the rule if the combination product or kit bears a UDI.
- Certain combination products that properly bear a National Drug Code number will not be required to bear a UDI. The device constituent of such a product is not required to bear a UDI if it is “physically, chemically, or otherwise combined or mixed and produced as a single entity.”
- Implantable devices will not need to be directly marked with a UDI.
- The final rule removes the prescriptive criteria of the proposed rule for determining the types of changes that result in a new version or model (requiring a new device identifier). Instead, labelers have discretion to determine when a change results in a new version or model.
Compliance dates differ for various types of devices. Key dates include the following:
- Within one year of publication of the final in the Federal Register (September 24), class III devices and devices licensed under the Public Health Service Act will need to bear a UDI, unless an extension is granted.
- Within two years, implantable, life supporting, and life-sustaining devices must bear a UDI, and certain of these devices must be directly marked with a UDI.
- Within three years, labels and packages of class II devices must bear a UDI.
- Within five years, labels and packages of class I devices and unclassified devices must bear a UDI.
FDA also has released a document entitled Draft Guidance for Industry: Global Unique Device Identification Database (GUDID), which provides information about submitting data to the Global Unique Device Identification Database. We will publish a post on FDA’s guidance document in the next several days.