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Letter/Comment
AHRMM LUC Comments to the FDA’s Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
The AHRMM LUC members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. They recommend that information related to all Class I Medical Devices be included in the GUDID without exception.
Learning UDI Community, Unique Device Identifier (UDI), Supply chain management, Regulatory Compliance, Patient Safety Risk, Medical Device Safety
Letter/Comment
AHRMM LUC Comments to the FDA’s Communications About the Safety of Medical Devices
The AHRMM LUC members submitted public comments and recommendations at the FDA's November 2020 meeting related to the need to include the UDI in the recall process. They highlighted the prototype recall database and electronic submission form, as well as survey data supporting its creation.
Learning UDI Community, Unique Device Identifier (UDI), Medical Device Safety, Supply chain management, Regulatory Compliance, Patient Safety Risk, Medical Device Regulation
Letter/Comment
AHRMM Comment Letter to FDA RE: “Modernizing FDA’s Data Strategy”
In September 2019, FDA announced its Technology Modernization Action Plan (TMAP).  The TMAP describes important near-term actions that FDA is taking to modernize use of technology—computer hardware, software, data and analytics—to advance FDA’s public health mission. The TMAP will provide a foundation for developing a more fluid, agile, and efficient FDA that is scaled to respond to novel technologies and a rapidly increasing workload.
Learning UDI Community, Unique Device Identifier (UDI), Medical Device Safety, Supply chain management, Regulatory Compliance, Patient Safety Risk, Serious Adverse Events, Medical Device Regulation
Letter/Comment
AHRMM Comment Letter to FDA Regarding the Draft Guidance for Industry on the Global Unique Device Identification Database (GUDID)
On November 21, 2013, AHRMM submitted electronically
Asset Management, Data Standards, Unique Device Identifier (UDI), Leadership