FDA has a unique device identification (UDI) system designed to identify medical devices through distribution and use. FDA recently issued final Guidance stating its intent to delay enforcement of certain requirements for class I and unclassified devices and devices that must be directly marked. FDA reports that manufacturers and labelers faced substantial costs in bringing existing products into compliance with FDA’s UDI policy. To combat these costs, FDA states that it intends to phase in the UDI system published on September 24, 2013, superseding a previous compliance policy issued on January 16, 2018. In the Guidance, FDA states its intent to delay enforcement of requirements for standard date formatting, labeling, and global unique device identification database (GUDID) data submission, as well as direct mark requirements for certain devices, as detailed below:

Standard date formatting, UDI labeling, and GUDID data submission

FDA does not intend to enforce standard date formatting, UDI labeling, and GUDID data submission requirements before:

  • September 24. 2020, for class I and unclassified devices; and
  • September 24, 2021, for finished class I and unclassified devices manufactured and labeled before September 24, 2018.

Direct marking

FDA does not intend to enforce direct marking requirements before:

  • September 24, 2018, for LS/LS devices manufactured and labeled before September 24, 2015;
  • September 24, 2019, for class III devices manufactured and labeled before September 24, 2016;
  • September 24, 2021, for non-sterile class II devices manufactured and labeled before September 24, 2018; and
  • September 24, 2022, for class I and unclassified devices.

The Guidance also states that FDA does not intend to enforce UDI direct mark requirements for class III, LS/LS, and non-sterile class II devices that were manufactured and labeled before the previously identified compliance dates when the device’s UDI can be derived from other information directly marked on the device, such as catalog numbers, lot numbers, and serial numbers. FDA intends the same for class I and unclassified devices that were manufactured and labeled before September 24, 2022.

FDA hopes the Guidance will reduce the risk of industry choosing to discard non-compliant devices rather than incur the additional costs to bring devices into compliance.

Readers may read the final Guidance, also available on FDA's website.

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