Understanding Permanent Marks and Methods for UDI Marking and Verification
Contributed by | Microscan
Direct Marking for FDA UDI Compliance
What is Unique Device Identification?
- GS1: www.gs1.org
- Health Industry Business Communications Council (HIBCC): www.hibcc.org
- International Council for Commonality in Blood Banking Automation (ICCBBA): www.iccbba.org
- A globally-standardized UDI code structure;
- A single, global database of all existing UDI codes;
- The ability to identify a device at any point in its lifecycle using the standardized UDI codes as cross-referenced with the global database.
What Does It Mean to “Permanently Mark” a Device?
What Is the Current FDA Guidance for UDI Direct Marking?
Which Medical Devices Require Direct Marks?
What Is “Reprocessing”?
What Are the Deadlines for Permanent UDI Marking?
What Part of the UDI Must Be Marked on a Device?
What Is the Required Format of a UDI Mark?
Which Data Carriers Should Be Used for Machine-Readable Marks?
Does the FDA Require a Specific Marking Method?
If the UDI on a Label Changes, Does the Directly-Marked UDI Need to be Replaced?
Do Company Names or Part Numbers Marked Directly to Devices Satisfy the UDI Requirements?
Can a Labeler Voluntarily Comply with Direct Marking Requirements?
Are there Exceptions to the UDI Direct Marking Rule?
Understanding Needs for Specific Applications
Challenges with Reading Direct Marks
What Can Be Done to Ensure Mark Quality and Compliance?
Why Is Choosing a DPM Verifier so Important?
Best Practices for Ensuring UDI Quality and Compliance
The content & opinions in this article are the author’s and do not necessarily represent the views of ManufacturingTomorrow
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