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

By AHRMM

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).

Related Resources

Advisories
Medical Device Tax Next Steps
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.
Senior Contract Specialist
Senior Contract Specialist job description.
Advisories
FDA Releases Proposed Rule on Unique Device System for Medical Devices
The FDA UDI ruling has finally arrived - the proposed rule has published.
Letters/Comments
AHRMM Comment Letter to FDA Regarding the Draft Guidance for Industry on the Global Unique Device Identification Database (GUDID)
On November 21, 2013, AHRMM submitted electronically
Advisories
Final Regulations on Taxable Medical Devices
The final regulations that provide guidance on the excise tax imposed on the sale of certain medical devices, enacted by the Health Care and Educ
Advisories
UDI and Adverse Event Reporting Advisory
The Food and Drug Administration (FDA) UDI system is being phased in over several years.