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AHRMM LUC Comments to the FDA’s Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
The AHRMM LUC members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices.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.
Recent Guidance on Meaningful Use of EHRs Makes Compliance More Difficult
Letter/Comment
Recent Guidance on Meaningful Use of EHRs Makes Compliance More Difficult.
AHRMM Comment Letter to FDA Regarding the Draft Guidance for Industry on the Global Unique Device Identification Database (GUDID)
Letter/Comment
On November 21, 2013, AHRMM submitted electronically
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Global Unique Device Identification Database (GUDID) Draft Guidance for Industry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.
AHA Recommendations to House Ways & Means Committee on Improving Health Care Access in Rural and Underserved Areas
Many hospitals including those in rural and underserved areas are experiencing unprecedented challenges that jeopardize access and services. Here are a series of proposals and suggestions for the Ways and Means Committee to consider as it looks for avenues to broaden access to health care for patients in rural and underserved regions.
AHRMM Statement on Comparative Effectiveness
Letter/Comment
AHRMM supports the concept and use of Comparative Effectiveness Research (CER) to provide evidence-based data to help inform purchasing decisions.
AHA Comments on IRS' Elective Payment of Applicable Credit Proposed Rule
The IRA, through the transferability provisions under Section 6418 and, in particular, the elective direct pay provisions of Section 6417, has provided new opportunities for the healthcare sector to engage in important clean energy initiatives.
AHA Letter of Support for the Drug Shortage Prevention Act of 2023
The Drug Shortage Prevention Act would require manufacturers to notify the Food and Drug Administration (FDA) of increased demand of covered drugs. The AHA believes the requirement that manufacturers notify the FDA of increased demand for critical drugs will be an integral tool for shoring up the supply chain.