The UDI Rule requires a device to bear a UDI on its label and packages. Special labeling requirements apply to standalone software regulated as a device. The UDI Rule also requires that data pertaining to the key characteristics of each device required to bear a UDI be submitted to FDA’s GUDID...

1. UDI Compliance Update
By: Nikita Angane
The UDI Rule requires a device to beara UDI on its label and packages. Special labeling requirements
apply to standalonesoftware regulated as a device. The UDI Rule also requires that data pertaining to the
key characteristics ofeach devicerequired to beara UDI be submitted to FDA’s GUDID.1
FDA’s Unique Device Identification rulewas designed to identify devices through its distribution and use.
A phased implementation strategy is being followed, which began in September 2014 through September
2020.1
The compliancedates established for class I and unclassified devices, otherthan implantable, life -
supporting,or life-sustaining (I/LS/LS) devices were:1
· September 24, 2018, for the following requirements:
o Standard date formatting
o Labeling, and
o Global Unique Device Identification Database (GUDID) data submission and
· September 24, 2020, for directmark requirements.
FDA realizes that because ofthe COVID-19 crisis, the industry is scrambling to meet the supply shortages,
and hence does not intend to enforce the standard date formatting, UDI labeling and GUDID data
submission requirements prior to September 24,2022.1
The compliancedate for direct marking ofclass IIIand class II non-steriledevices was Sept 24, 2016and
September 24, 2018, respectively.The manufacturers werenot required to comply with the UDI
requirements until 3 years after the labeling compliance date. However, in its latest guidance document,
FDA mentions that it does not intend to enforceUDI Direct Mark requirements when the UDI can be
obtained from other information which is directly markedon the device.1
The direct mark compliance dates for class I and unclassified devices is Sept 24, 2020.However, due to
the pandemic and after realizing the cost to remediateexisting devices in inventory to add a direct mark,
FDA does not intend to enforce UDI direct mark requirements prior to Sept 24, 2022.1
Additionally,after September24, 2022,FDA does not intend to enforceUDI direct mark requirements for
finished class I and unclassified devices, that were manufactured and labeled prior to September 24,
2022, and that remain in inventory, when the device’s UDI can be derived from otherinformation directly
marked on the device.1
Need help with your UDI labeling?Call us today at 248-987-4497 or email us at
info@emmainternational.com.
1 FDA (July 2020) Unique Device Identification:Policy RegardingComplianceDates for Class I and Unclassified
Devices and Certain Devices RequiringDirectMarkingretrieved on 07/01/2020 from
https://www.fda.gov/media/110564/download