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AHA Comments on the Remanufacturing of Medical Devices, Draft Guidance for Industry and FDA Staff

AHA comments on the Remanufacturing of Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff.

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