Industry News

Unique Device Identifier Required for Class III Medical Devices

In FDA, MRO, Regulatory by Anney Majewski

September 24th, 2014 will not only be the one-year mark for the publication of the final rule for the Unique Device Identification System (UDIS) as announced by the Food and Drug Administration (FDA), but it will also be the effective date of compliance for a series of provisions. The requirements call for all labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act), including IVDs, to have a UDI (unique device identifier). All dates on the labels of these devices must be formatted to the standards mandated by § 801.18, and data for these devices be submitted to GUDID (The Global UDI database). Class III stand-alone software must also provide a UDI under the new stipulations. If desired, a 1-year extension for this date may be requested, but it needs to be submitted no later than June 23, 2014.

UDI Final Rule Provisions as of 9/24/2014:

  • Labels and packages of class III medical devices and devices licensed under PHS Act to have a UDI
  • Dates on the labels of these devices to be formatted to the standards mandated by § 801.18
  • Data for these devices be submitted to GUDID
  • Class III stand-alone software to provide a UDI

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Authors:

Anney Majewski is the Marketing Communications Specialist at NAMSA, focusing on expanding the overall knowledge and understanding in the medical device industry. She obtained a BBA in Marketing from the University of Toledo as well as an A.S. in Psychology from Monroe County Community College.