Yesterday the FDA posted a new document on their website with the title, “Unique Device Identification System: Small Entity Compliance Guide, Guidance for Industry and Food and Drug Administration Staff”. The document is 23 pages long and it includes an explanation—in what the FDA calls “plain language”—of the FDA’s Unique Device Identification (UDI) system and the Global Unique Device Identification Database (GUDID). It is aimed at small businesses, but it is a good read for anyone who wants an overview of the regulation. The guidance contains non-binding recommendations for companies who must meet the UDI final rule, including makers of class III medical devices, which must comply by September 24 of this year.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of RxTrace. The material contained in RxTrace is not legal advice. The writers of RxTrace are not lawyers. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than RxTrace.