FDA GUDID: what it is, who must submit, and what to prepare
Plain-language primer on the U.S. FDA GUDID database (UDI/Device): scope, key data, submission flow, and common pitfalls.
We support UDI Ops across Swissdamed / EUDAMED / FDA GUDID with controlled datasets, validated exports, and evidence logs.
- Source-linked guidance (official first). When we reference requirements, we link official FDA guidance and data attribute definitions.
- Private detail sharing. Templates, mappings, and delivery flow details are shared under private agreement and limited scope.
- Traceable outputs. We attach validation notes, change logs, integrity manifests, and checksums where appropriate.
- Practical readiness. Focus: reduce avoidable rework before submission, and keep an audit narrative you can defend.
What is GUDID?
GUDID is the U.S. FDA’s Global Unique Device Identification Database. It stores device identification and core device attributes linked to the UDI-DI, supporting traceability and transparency.
Who must submit?
- Labelers (as defined by FDA) are responsible for creating and maintaining GUDID records.
- Organizations need appropriate accounts/roles and controlled source data for consistent updates.
What data is typically required?
Typical GUDID records include device identifiers, device description, packaging configurations, safety attributes, and regulated vocabulary fields (where applicable). Data quality and internal consistency matter more than volume.
Submission flow (high level)
- Define scope and assemble a controlled dataset (single source of truth).
- Normalize and validate fields (formatting, controlled vocabularies, cross-field consistency).
- Submit via FDA’s supported channels (manual entry or structured bulk submission, depending on your setup).
- Keep an evidence trail: change log, validation notes, and integrity verification for deliverables.
Common pitfalls
- Inconsistent packaging levels and DI relationships across records.
- Missing or unstable reference data (contacts, brand/device naming conventions).
- Vocabulary mismatches and formatting issues that trigger avoidable rework.
- Operating without a controlled dataset (changes spread across spreadsheets and emails).
What we deliver
- Submission-ready pack (target-formatted files + operator notes).
- Evidence pack (change log, validation notes, integrity manifest, checksums).
- Readiness gates (clear “done” criteria before you submit).
Official references
When in doubt, verify against official FDA sources. We also maintain a curated Standards & References page.