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Public

AHA Comments on Commerce Department Investigation of Pharmaceutical Imports

AHA comments on the Department of Commerce’s request for public comment on its Section 232 national security investigation on pharmaceutical and pharmaceutical ingredient imports.
Supply chain management, Tariffs
Public

AHA Responds to Commerce Department Investigation of Critical Minerals

AHA comments on the Department of Commerce’s request for public comment on its Section 232 national security investigation on processed critical minerals and derivative products.
Medical Device Purchasing, Medical Device Technology, Supply chain management, Tariffs
Public

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.
Supply chain management, Medical Device Purchasing, Drug Prices, Drug shortages, Tariffs
Public

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.
Supply chain management, Emergency Readiness

AHRMM LUC Comments to the FDA’s Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices

The AHRMM LUC members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices.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

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
Cost, Quality and Outcomes (CQO) Movement, Data Standards, Materials Management Information System (MMIS), Regulations and Regulatory Advocacy, Suppliers, Leadership

IRS Issues Final Rule Implementing Medical Device Excise Tax

Letter/Comment
An announcement of the Final Rule issued by the IRS.
Capital Equipment, Distribution, Regulations and Regulatory Advocacy, Procurement

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.
Benchmarking, Products and Services Contracting, Distribution, Financial Management, Lean/Six Sigma, Strategic Planning

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

AHRMM Comment Letter to FDA RE: “Modernizing FDA’s Data Strategy”

In September 2019, FDA announced its Technology Modernization Actio
Learning UDI Community, Unique Device Identifier (UDI), Medical Device Safety, Supply chain management, Regulatory Compliance, Patient Safety Risk, Serious Adverse Events, Medical Device Regulation