Sam Lazzara
Trusted Information Resource
I have drafted this high level task list intended for medical device labelers who want to implement FDA requirements for Unique Device Identification. Did I miss anything?
1. Determine FDA 21 CFR requirements applicable to your devices.
2. Perform gap analysis between FDA requirements and current quality system.
3. Create Quality Plan for UDI implementation.
4. Select FDA-accredited issuing agency.
5. Select and procure label printing system (printer and software). If needed also select and procure device marking system.
6. Design and procure package label stock(s) with primary printing.
7. Choose barcode style to be used for UDI.
8. Develop secondary/production label printing ?artwork? using software. Same goes for device markings if required.
9. Select and procure barcode verification system.
10. Update quality system documents to support UDI implementation.
11. Verify/validate UDI application process (protocol, execution, report).
12. Confirm implementation readiness per Quality Plan, enter UDI information into FDA Global UDI Database (GUDID), and GO LIVE!
I continue to update this page with new UDI related info when I see it.
1. Determine FDA 21 CFR requirements applicable to your devices.
2. Perform gap analysis between FDA requirements and current quality system.
3. Create Quality Plan for UDI implementation.
4. Select FDA-accredited issuing agency.
5. Select and procure label printing system (printer and software). If needed also select and procure device marking system.
6. Design and procure package label stock(s) with primary printing.
7. Choose barcode style to be used for UDI.
8. Develop secondary/production label printing ?artwork? using software. Same goes for device markings if required.
9. Select and procure barcode verification system.
10. Update quality system documents to support UDI implementation.
11. Verify/validate UDI application process (protocol, execution, report).
12. Confirm implementation readiness per Quality Plan, enter UDI information into FDA Global UDI Database (GUDID), and GO LIVE!
I continue to update this page with new UDI related info when I see it.