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FDA Class I UDI Submission Deadline
FDA Class I
Class I devices and devices that have not been classified into class I, class II or class III that are required to be labeled with a UDI code, must submit product data to the FDA’s GUDID by September 24, 2022 (moved from September 24, 2020). FDA announced a two-year shift of the enforcement of this compliance date on June 30, 2020.
If you’ve already started the process, keep that momentum going. Contact Reed Tech for experienced help and check this off your list. Learn more about how we can help.
Class I Basic UDI Account:
- Simple step-by-step guidance for registration
- Validation and acknowledgment
- Submission meets all technical components of CFR Part 11 requirements
Need expert help with UDI submissions to FDA?
Download this quick reference of ‘What to Know’ when it comes to Class I UDI compliance for 2022.