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FDA issues Small Entity Compliance Guidance for UDI


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The US Food and Drug Administration (FDA) has issued a guidance document titled ?Unique Device Identification System Small Entity Compliance Guide?. This guidance gives overview of the UDI regulation and how to comply with the labeling requirements, communications with an issuing agency, GUDID data submission requirements, and Exceptions and Alternatives to the UDI Requirement.

This guidance is intended primarily to provide information to the medical device industry, including small businesses, concerning FDA?s September 24, 2013, final rule establishing a unique device identification system; see 78 FR 58786 et seq. It provides an overview of the UDI Rule?s regulatory requirements and discusses the actions a small entity should take to meet those requirements. - page 4 of 23

To access the said guidance document, please refer here.


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