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FDA Grants Implant Manufacturers a One Year Extension on UDI Labeling Compliance


FDA Grants Implant Manufacturers a One Year Extension on UDI Labeling Compliance

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On November 19, 2014, the Food and Drug Administration released a one year extension on UDI labeling compliance for many implantable medical device manufacturers. Implantable medical device manufacturers with devices that meet all of the following criteria (1) classified with primary codes and regulations listed in the November 19 extension letter, (2) single use implants, […]

FDA issues Small Entity Compliance Guide on UDI

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Today the Food and Drug Administration is making available Unique Device Identification System: Small Entity Compliance Guide (SECG): Guidance for Industry and Food and Drug Administration Staff. FDA is issuing this guide as level 2 guidance consistent with FDA’s good guidance practices regulation. While Level 2 guidance documents are posted for immediate implementation, comments on […]