FDA Medical Device Unique Device Identifier requirements review during import entry
Published May 22, 2023
Summary
CBP reiterates FDA's Unique Device Identification (UDI) requirements for medical devices at import, noting that entries lacking a UDI label or matching GUDID record may be refused, and provides resources for compliance and detained-entry remediation via FDA Form FDA-766.
Summary is machine-generated at the linking layer for discovery only. Refer to the source bulletin for authoritative guidance.
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