FDA UDI Implementation in 12 Steps

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.

  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. Become member and obtain company prefix.
  5. Select and procure label printing system (printer and software). Same goes for device marking system if required.
  6. Design and procure package label stock(s) with primary printing.
  7. Choose barcode style to be employed on package labels and/or device itself.
  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!  Inform customers – consider publishing a product catalog that cross references REF/Catalog numbers versus Device Identifier numbers.Screen Shot 2017-06-06 at 5.22.40 PM.png
    FDA UDI (DI+PI) FAQ, Sam Lazzara, ASQ Biofeedback

Published by Sam Lazzara

Sam Lazzara is a Biomedical Engineer (MS Case Western, BS Brown University) and Certified Biomedical Auditor with 30+ years medical device experience. Sam’s systems and documents have delighted dozens of regulatory auditors from the United States FDA, the California Department of Health, and a flock of European Notified Bodies. He has guided quality system implementation for over 20 firms, leading to third-party certification and government approvals. A medical device start-up specialist, Sam provides state-of-the-art solutions tailored to the needs of each client. He mentors clients on all aspects of quality assurance and regulatory affairs. Sam gets particularly excited about design control, risk management, and post-market surveillance.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s