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).
Related Resources
Case Studies
A UDI Capture Work Group Case Study at the Baptist Health.
Webcast
In part one, we explore the reasons why the FDA created the (UOU) Unit of Use.
Webcast
In the third part of the the FDA Unique Device Identification (UDI) “Unit of Use” (UOU) webcast series, we cover several potential use cases for th
Webcast
In part two of the FDA Unique Device Identification (UDI) Unit of Use (UOU) webcast series, we cover the FDA definition of the term, Unit of Use.
Case Studies
WORK GROUP TITLE:
UDI Capture Work Group
CASE STUDY PARTICIPANTS:
Case Studies
WORK GROUP TITLE:
UDI Capture Work Group
CASE STUDY PARTICIPANTS: