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AHRMM LUC Comments to the FDA’s Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
The AHRMM LUC members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices.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.
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.
AHRMM Comment Letter to FDA RE: “Modernizing FDA’s Data Strategy”
In September 2019, FDA announced its Technology Modernization Actio