U.S. FDA Global Unique Device Identification Database (GUDID) and Unique Device Identifiers (UDI
FDA has established a Unique Device Identification system to identify medical devices through their distribution and use in hospitals and other practices. Through this universal system, the label of most devices should include a Unique Device Identifier (UDI) in a human and machine-readable format. FDA also requires Medical Device labelers to submit certain information about each device including UDI to FDA’s Global Unique Device Identification Database (GUDID). IRAOmega can assist you in deciding if FDA’s UDI is required for your device as well as submitting your device information to FDA’s Global Unique Device Identification Database (GUDID). Click the start button for free initial assessment and GUDID submission and UDI assistance.
Service & Fees:
- Initial Assessment Determining if UDI/ GUDID submission Needed, Free
- GUDID submission,195 USD
- One Year Revisions and Reviews, Free
- GUDID Verification and Interim Updates, Free