In just five months, firms marketing Class II medical devices will be required to comply with the U.S. Food and Drug Administration's (FDA) unique device identification (UDI) requirements and date formatting requirements. Companies marketing Class II devices should ensure that they are on track to meet the September 24, 2016, deadline.
A UDI is a unique numeric or alphanumeric code that consists of two parts:
- A device identifier (DI), which is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device; and
- A production identifier (PI), which is a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
- The lot or batch number within which a device was manufactured;
- The serial number of a specific device;
- The expiration date of a specific device;
- The date a specific device was manufactured; and/or
- The distinct identification code required by 21 C.F.R. §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.
By way of background, in 2013, the FDA released a final rule establishing a UDI system designed to adequately identify devices through distribution and use. The final rule requires device labelers to include a UDI on device labels, packages, and in some cases, on the device itself (e.g., for a device that is intended for more than one use and intended to be reprocessed before each use). Each UDI must be provided in a plain-text version and in a form that uses machine-readable automatic identification and data capture (AIDC) technology. In addition, the rule requires that dates on device labels and packages be presented in a standard format that is consistent with international standards and international practice.
By September 24, 2016:
- The labels and packages of Class II medical devices must bear a UDI;
- Dates on the labels of Class II devices must be formatted as required by the FDA's UDI regulations;
- Stand-alone software that is a Class II device must provide its UDI as required by the FDA regulations; and
- Data for Class II devices that are required to be labeled with a UDI must be submitted to the FDA's Global Unique Device Identification Database (GUDID).
The FDA is already accepting GUDID account requests from labelers of Class II devices, and the agency is encouraging these firms to obtain a GUDID account as soon as possible to allow adequate time for system compatibility testing and data submission.
Finally, the FDA recently issued draft guidance to help companies marketing convenience kits, including first aid kits, comply with the UDI requirements.