ADA - 1081
FDA's Unique Device Identification (UDI) Program for Dental Devices and Biologics Regulated as Medical Devices
active, Most Current
| Organization: | ADA |
| Publication Date: | 1 January 2019 |
| Status: | active |
| Page Count: | 15 |
scope:
The FDA has issued a rule to establish a system to adequately identify devices through distribution. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement.
Document History
1081
January 1, 2019
FDA's Unique Device Identification (UDI) Program for Dental Devices and Biologics Regulated as Medical Devices
The FDA has issued a rule to establish a system to adequately identify devices through distribution. This rule requires the label of medical devices to include a unique device identifier (UDI),...
January 1, 2015
ADA Technical Report No. 1081 for FDA's Unique Device Identification Program for Dental Devices - ADA1081-2015
This report provides a technical specification based on the DICOM Standard as it applies to dentistry with the goal of increasing interoperability within and between institutional digital...