Hi All,
FDA published a final rule establishing a unique device identification system (UDI Rule). It requires the labels and device packages of medical devices distributed in the United States include a unique device identifier, unless we grant an exception or alternative to UDI label requirements. The UDI Rule also requires specified product information be submitted to FDA's Global Unique Device Identification Database (GUDID). This guidance document provides the FDA's recommendations on the information necessary for labelers submitting data to GUDID. FDA has updated this document to reflect changes to the Global Medical Device Nomenclature (GMDN) field in GUDID. The option to use FDA Preferred Terms (FDA PT) Codes will be removed because FDA PT codes are no longer necessary since GMDN Terms are now available without a paid membership.
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Michael Roza CPA, CISA, CIA, CC, CCSKv5, CCZTv1, MBA, EMBA, CSA
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