HIDA Government Affairs Alert

September 7, 2016

FDA Heeds HIDA Recommendations: Announces 2 Year UDI Compliance Deadline Extension

As a result of HIDA member advocacy with the FDA and our 100+ Hill meetings at the Washington Summit, FDA issued guidance extending the compliance date for UDI labeling and Global Unique Device Identification Database (GUDID) submission requirements for some Class II devices to September 24, 2018.

Specifically the guidance applies to:

  • Collections of two or more different class II, or class II and class I devices (other than devices that are implantable, life-sustaining or life-supporting) packaged together, in which the devices in the package are not individually labeled with a UDI; and
  • Repackaged class II single-use devices (other than devices that are implantable, life-sustaining or life-supporting) that are not individually labeled with a UDI.

Additionally, the agency is clarifying that for device constituents of certain combination products (other than devices that are implantable, life-sustaining or life-supporting) the compliance date for UDI labeling and GUDID submission requirements is September 24, 2018.

Additional UDI Related Activity

The FDA continues to receive and evaluate labeler requests for an exception from or alternative to the UDI requirements according to the provisions of 21 CFR 801.55. 21 CFR 55(c) outlines the circumstances under which the FDA may determine that an exception or alternative is appropriate. Any labeler may make use of a UDI exception or alternative granted by the FDA provided that such use satisfies all safeguards or conditions that are part of the exception or alternative. To facilitate such use, the FDA has begun making decisions on labeler requests for exceptions and alternatives available on the "FDA Decisions" tab on the UDI Exceptions, Alternatives and Time Extensions webpage.

The FDA released a final guidance document, “Enforcement Policy on National Health Related Item Code (NHRIC) and National Drug Code (NDC) Numbers Assigned to Devices” on August 30, 2016. The guidance was issued in draft on February 3, 2016. This guidance describes the Agency’s intent not to enforce the prohibition against providing NHRIC or NDC numbers on device labels and device packages, with respect to finished devices that are manufactured and labeled prior to September 24, 2021. The guidance also describes the Agency's intent to continue considering requests for continued use of FDA labeler codes under a system for the issuance of UDIs that are submitted before September 24, 2021. This guidance does not affect continued implementation of UDI label and GUDID submission requirements according to the compliance dates established by the FDA.

The FDA released a draft guidance document, "Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)" on July 26, 2016. This draft guidance is intended to assist labelers and FDA-accredited issuing agencies (IAs) better ensure the UDIs developed under IA systems are in compliance with the UDI rule. Although comments can be submitted on any guidance at any time, to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments by September 26, 2016.

For additional information on UDI and its impact on HIDA’s membership, contact Amy Kohl at (703) 838-6121 or kohl@hida.org.