On September 24, 2013, the Food and Drug Administration (FDA) published a final regulation requiring medical devices distributed in U.S. commerce to carry a unique device identifier (UDI). Importantly, the UDI labeling requirements will be phased in over time, beginning with higher risk Class III medical devices, which will be required to be labeled with a UDI as of September 24, 2014. The UDI requirements also apply to certain combination products that contain devices, as well as certain devices licensed under the Public Health Service Act. Companies seeking to obtain a UDI will be required to submit an application to an FDA-accredited “issuing agency” for each type of device subject to the regulation. In order to become an issuing agency, a company/organization would need to apply to FDA to become accredited for such a purpose. Companies likely to seek FDA accreditation include companies currently accredited by FDA to serve as Third-Party (medical device) Reviewers and/or Notified Bodies that currently serve the EU regulatory system. However, FDA’s accreditation of issuing agencies has not yet begun, so it may be several months before more is known about this aspect of the UDI regulatory process.

A unique device identifier or UDI is comprised of a unique numeric/alphanumeric code that consists of (1) a device identifier (DI), which is the part of a UDI that identifies the labeler and the specific version or model of a device, and (2) a production identifier (PI), which is a conditional or variable portion of a UDI that identifies information such as batch/lot number, expiration date, serial number, date of manufacture, or other unique device information.

The second component of the UDI regulation is the creation of a publicly searchable, FDA administered database known as the “Global Unique Device Identification Database (GUDID),” which will serve as a reference catalogue for devices. Device companies will be required to submit UDI information to GUDID electronically on or before the date a given UDI labeled device is introduced into commerce. To support this submission process, FDA has issued draft guidance entitled, “Global Unique Device Identification Database (GUDID) - Draft Guidance for Industry,” to assist device companies with the preparation and submission of UDI information to the GUDID. No identifying patient information will be stored in GUDID.

As noted above, the regulation calls for the phase-in of the UDI requirements based on class of device or intended use. The following devices must be labeled with a UDI by the specified date:  

  • Class III (PMA) devices  must be labeled with a UDI by September 24, 2014;
  • Devices that are implantable, life-supporting or life-sustaining must be labeled with a UDI by September 24, 2015;
  • Class II devices must be labeled with a UDI by September 24, 2016; and
  • Class I and unclassified devices must be labeled with a UDI by September 24, 2018.
  • Any device intended for reuse that requires reprocessing before each use will also eventually need to be permanently marked with a UDI directly on the device.

Based on the regulation’s requirements, medical device companies, especially larger companies that market hundreds of different devices, will likely soon be faced with increasing regulatory workloads and compliance costs in order to comply with the regulation. Arent Fox is working with device companies to help implement the new requirements in an efficient and effective manner. We also are monitoring FDA’s continuing implementation of this important new medical device regulation.