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U.S. FDA Unique Device Identifier (UDI) and Global Unique Device Identifier Database (GUDID) Requirements

21 C.F.R. § 830 (2016)

The U.S. FDA requires medical device labelers to:

  • Include Unique Device Identifiers (UDI) on their device labels
  • Submit device information to the Global Unique Device Identification Database (GUDID)
  • Designate a Regulatory Contact for UDI purposes

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