Area of focus

Unique Device Identifiers

Handling the U.S. Food and Drug Administration’s (FDA) rules regarding unique device identifier (UDI) obligations requires regulatory and technical knowledge. Do you understand your requirements? The lawyers at Hogan Lovells advise clients regarding the specifics of the UDI rule, including applicable exceptions,...

Representative experience

Work with a Fortune 50 company to develop governing procedures for implementation to ensure compliance and add business value.

Obtained compliance extension to ensure device availability for critically ill population and exceptions to labelling requirements due to technological constraints.

Advise companies on nuanced implementation for convenience kits and private label distributions.

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