The 1WorldSync Training team created the FDA Quick Sheets to help you quickly get started with a basic overview of the steps you will take to successfully synchronize your product content with the FDA. It would also help you to review the FDA Implementation Guide to understand the steps you will follow to completion. In addition to these helpful tools, below is a list of common issues that new FDA information providers encounter along with some points for additional guidance.
- As a medical device information provider, you will be asked to provide information that is standard with these types of products. Please make sure to have your GMDN Codes, Product Classification Database Codes, and Pre-Market Submission Codes as the FDA will need these from you during this process.
- There are a few very important steps that kick off this process for you that are often missed and can lead to confusion and delays.
- Request your GLN to be set up in the 1WorldSync Pre-Production environment by contacting 1WorldSync Access Management at accessmanagement@1worldsync.com
- Apply for a Preproduction account at the FDA, access the FDA account application form at: https://www.fda.gov/medical-devices/global-unique-device-identification-database-gudid/request-gudid.... On the form under the Indicate GUDID Submission Option select HL7 SPL Preproduction, not a GUDID Web Interface account. Request HL7 SPL accounts for both Pre-Prod AND Production.
- Select 1WorldSync as your (third-party) partner and fill in 1WorldSync’s address as 1WORLDSYNC INC., 300 S Riverside Plaza #1400, Chicago, IL 60606. Also, the 1WorldSync DUNS number is 037407777.
- The synchronization process with the FDA has impactful timing restrictions throughout so be sure to understand when you have a small timing window to communicate content and changes to the FDA. Refer to Section 3.6 of the FDA Implementation Guide for the attributes that cannot be changed and/or added after the FDA’s grace period. These rules are referred to in the FDA’s 6 test scenarios. For products published to the FDA GUDID and the UDID First Publication Date Time (udidFirstPublicationDateTime) is more than 7 days in the past, some attributes cannot be added, deleted, or edited. If changes are needed after this date, the labeler must log into Access GUDID to open the item for modifications.
- Understand the unique testing process in Pre-Prod for product approval before you can synchronize your product content in Production with the FDA. The FDA Quick Sheets and FDA Implementation Guide (Section 3.1) detail these steps for you.
- Note, that the FDA Pre-Prod GLN is 1100001017041 and the FDA Production GLN is 1100001017041.
Additional Resources
FDA - Quick Sheets for GUDID
FDA GUDID Implementation Guide
Access the GUDID Help Desk
Test FDA GUDID Load Sheet FUSE
FDA GUDID Mapping Guide
