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AHA Urges Administration to Grant Exceptions for Tariffs for Medications and Medical Supplies
The AHA asks President Trump to consider granting exceptions to the current and proposed tariffs for medical devices and pharmaceuticals made in Mexico, Canada and China that are essential to the provision of safe, effective care in America's hospitals, clinics, and other settings.
AHA to President Urging the Administration to Take Action to Address IV Solution Supply Shortage as a Result of Helene
AHA letter to President Biden urging the Administration to take action to address IV solution supply shortage as a result of hurricane Helene.
AHA Comments on the Proposed Change to Section 301 Tariffs for Goods Made in China – 90183100
June 28, 2024 The Honorable Katherine TaiU.S. Trade Representative600 17th Street NWWashington, DC 20508
AHRMM LUC Comments to the FDA’s Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
The AHRMM LUC members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices.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.
The Official Comment of AHRMM to the United States Department of Health and Human Services Food and Drug Administration (FDA) regarding Unique Device Identification for Medical Devices Docket No. FDA-2011-N-0090
Letter/Comment
AHRMM comments to the FDA regarding an amendment to the UDI proposed rule to address the UDI implementation time frame required by the 2012 Food and Drug Administration Safety and Innovation A
IRS Issues Final Rule Implementing Medical Device Excise Tax
Letter/Comment
An announcement of the Final Rule issued by the IRS.
Global Unique Device Identification Database (GUDID) Draft Guidance for Industry
Letter/Comment
This page provides information about submitting data to the database for device Labelers, entities responsible for providing the data to the GUDID.
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