On August 13, The FDA issued a guidance for industry and FDA staff called “Unique Device Identification System: Small Entity Compliance Guide”. 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.

It provides an overview of the UDI Rule’s regulatory requirements and discusses the actions a small entity should take to meet those requirements. FDA's guidance documents describe the agency’s current suggestions and recommendations, but state that manufacturers can use an alternative approach as long as it satisfies the requirements of the applicable statutes and regulations.

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