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
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 Act (FDASIA).
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Magazine & Journal Articles
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Toolkits/Methodology
How to write a constructive, information-rich comment that clearly communicates and supports its claims to have an impact on regulatory decision…
Guides and Reports
In 2001 the Institute of Medicine (IOM) published
Issue Brief
The Medical Device Excise Tax, a component of the Affordable Care Act, is approaching implementation at the beginning of 2013.
Letter/Comment
Recent Guidance on Meaningful Use of EHRs Makes Compliance More Difficult.
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.