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FDA Extends UDI Compliance Date for Class I Devices to 2020

On June 2, 2017, the U.S. Food and Drug Administration issued a letter announcing that the Agency intends to extend the Unique Device Identification (UDI) compliance dates for class I and unclassified devices (excluding implantable, life-supporting or life-sustaining devices) to September 24, 2020 (two years after the original compliance date).  FDA plans to solidify this extension with a guidance document regarding its enforcement discretion, but the Agency wanted to inform industry of its decision as early as possible.

Device labelers are responsible for implementing FDA’s UDI requirements.  According to the letter, many labelers asked FDA for an extension upon realizing the substantial amount of time the process takes.  The letter also notes that “providing accurate and timely support to labelers has also been challenging, due to the sheer number and wide diversity of devices,” which leads us to believe many labelers are having difficulty completing the process on their own.

With this in mind, it’s prudent for device labelers to begin preparing for the 2020 UDI compliance date as early as possible to ensure they meet the requirements on time.  Registrar Corp’s Regulatory Specialists can help you navigate the UDI process, including obtaining a DUNS number, calculating how many UDIs you will need, and more.  For assistance, simply complete the form below:





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