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FDA issues UDI Compliance Extension for Certain Class II Devices

On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued an extension to the Unique Device Identification (UDI) compliance deadline for certain class II devices. The original compliance date of September 26, 2016 for the UDI label and submission of data to the Global Unique Identification Database (GUDID) has been extended to September 24, 2018.

The extension to the UDI rule applies to the following class II devices and constituents of certain combination products:

  1. Collections of two or more different devices packaged together in which the devices in the package are not individually labeled
  2. Repackaged single use devices (This extension does not apply to implantable, life-supporting or life sustaining devices.)
  3. Combination products assigned to FDA’s Center for Drug Evaluation and Research (CDER) or FDA’s Center for Biologics Evaluation and Research (CBER) for premarket review

FDA extended the compliance deadline for collections of two or more different devices packaged together to allow the agency time to finalize their draft guidance document titled “Unique Device Identification: Convenience Kits: Draft Guidance for Industry and Food and Drug Administration Staff.”  The deadline for repackaged single use devices is extended only to single use devices that are not individually labeled with an UDI.

Other class II devices are still required to comply with FDA’s UDI rule by September 24, 2016.  Click here for tips for meeting this month’s deadline.

The UDI rule created a system that aims to identify medical devices from their distribution to the supply chain point of use with patients.  Registrar Corp put together a short video on FDA’s UDI requirements.

For assistance with FDA’s UDI requirements or determining your compliance date, contact Registrar Corp at +1-757-224-0177 or talk to a Regulatory Advisor at www.registrarcorp.com/livehelp 24 hours a day.