Search Results
The default setting for search results displays All Content. If you prefer to see recent content only, please adjust the date filter.
Filter your results:
Types
Topics
33 Results Found
New Guidance on Humidity Levels in the Operating Room
Advisory
New Guidance on Humidity Levels in the Operating Room
AHRMM LUC Comments to the FDA’s Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
The AHRMM LUC members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices.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.
Medical Device Excise Tax - What You Should Know
Issue Brief
The Medical Device Excise Tax, a component of the Affordable Care Act, is approaching implementation at the beginning of 2013.
Medical Device Tax Next Steps
Advisory
The medical device excise tax is a feature of the Affordable Care Act. It is important to be knowledgeable about the tax and its effects.
AHRMM Awareness Brief: Draft Guidance for UDI Convenience Kits
Issue Brief
This Awareness Brief provides a quick reference to the Draft G
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
Final Regulations on Taxable Medical Devices
Advisory
The final regulations that provide guidance on the excise tax imposed on the sale of certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010 in conjunction wi
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Global Unique Device Identification Database (GUDID) Draft Guidance for Industry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.
CMS Releases Final Rules for CY 2011 Hospital Outpatient/ASC Payment System, Physician Fee Schedule and Home Health Payment System
Advisory
An overview of the Centers for Medicare & Medicaid Services' three final rules for calendar year 2011 the outpatient prospective payment system and ambulatory surgical center rule, the Me