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

Issue Brief
Alarm Safety Management
This learning lab covers alarm safety management in the health care supply chain field.
Advisory
FDA Releases Proposed Rule on Unique Device System for Medical Devices
The FDA UDI ruling has finally arrived - the proposed rule has published.
Advisory
UDI and Adverse Event Reporting Advisory
The Food and Drug Administration (FDA) UDI system is being phased in over several years.
Advisory
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
Advisory
Special Fraud Alert: Physician-Owned Entities
This Special Fraud Alert focuses on the specific attributes and practices of PODs that OIG believes produce substantial fraud and abuse risk and pose…
Magazine & Journal Articles
A Broader Focus for Tomorrow's MMs
AHRMM's Cost, Quality, and Outcomes (CQO) Movement will provide training and education to help supply chain professionals make the correlation…