Why FDA Labelling and UDI Compliance
are Essential?
Legal background
FDA labelling rules ensure your device is correctly identified, traceable, and safely used by healthcare professionals and patients. Compliance also facilitates device tracking and post-market surveillance, helping maintain patient safety and regulatory confidence.
By ensuring compliance, you benefit from:
-
- Smooth access to the US market
- Clear, compliant labelling that supports safe device use
- Enhanced traceability through proper UDI implementation
- Stronger confidence among healthcare professionals and distributors
Our services
How Obelis USA Ensures Your Medical Device Meets FDA Labelling and UDI Requirements
Obelis provides end-to-end support to ensure your labelling and UDI meet FDA requirements seamlessly:
- Label and IFU Review: We verify your materials for compliance with FDA content and formatting requirements.
- Symbol Validation: We ensure all medical device label symbols align with FDA-recognized standards.
- UDI Assignment Guidance: We help assign UDIs correctly to devices, packaging levels, and kits.
- FDA GUDID Submissions: Our team manages your UDI data submission and maintenance in the FDA Global UDI Database.
- Regulatory Monitoring: Stay compliant through continuous tracking of FDA labelling and UDI regulation updates.
With Obelis as your partner, you can ensure your documentation is fully compliant, paving the way for secure, compliant, and efficient market access in the United States.
FAQ
Frequently Asked Questions
UDI is a system required by the FDA that assigns a unique code to each medical device to improve traceability, post-market surveillance, and patient safety.
Labels must include the manufacturer’s details, intended use, warnings, IFUs, and applicable medical device label symbols.
The FDA GUDID (Global Unique Device Identification Database) stores detailed information on medical devices for regulators, healthcare providers, and the public.
The device manufacturer must ensure the UDI is properly assigned and uploaded to the FDA GUDID.
We review your labelling, help with UDI assignments, support GUDID submissions, and provide ongoing updates on regulatory changes.
