Here is a high level task list intended for medical device labelers who want to implement FDA requirements for Unique Device Identification. Check out this blog page for general information related to UDI.
- Determine FDA 21 CFR requirements applicable to your devices.
- Perform gap analysis between FDA requirements and current quality system.
- Create Quality Plan for UDI implementation.
- Select FDA-accredited issuing agency. Become member and obtain company prefix.
- Select and procure label printing system (printer and software). Same goes for device marking system if required.
- Design and procure package label stock(s) with primary printing.
- Choose barcode style to be employed on package labels and/or device itself.
- Develop secondary/production label printing “artwork” using software.Same goes for device markings if required.
- Select and procure barcode verification system.
- Update quality system documents to support UDI implementation.
- Verify/validate UDI application process (protocol, execution, report).
- Confirm implementation readiness per Quality Plan, enter UDI information into FDA Global UDI Database (GUDID), and GO LIVE! Inform customers – consider publishing a product catalog that cross references REF/Catalog numbers versus Device Identifier numbers.
FDA UDI (DI+PI) FAQ, Sam Lazzara, ASQ Biofeedback