# FDA Global UDI Database (GUDID) Submission & Compliance Spec
> Validate medical device UDI records against FDA GUDID data requirements before submitting to the FDA.

- **Canonical URL:** https://stanzaapi.com/tools/udi-decoder/standard/fda-gudid-spec
- **Governing Standard:** FDA 21 CFR 801.20 / EU MDR 2017/745 (FDA AccessGUDID Database & IMDRF)
- **Latency:** <2ms Edge
- **Privacy:** In-memory execution only (zero data stored or logged)

## Technical Overview & Governing Rules
GUDID serves as the reference catalog for every medical device with an assigned UDI sold in the United States.

## Specification Matrix
| Field | Requirement | Description |
| --- | --- | --- |
| Primary DI Number | Mandatory | GTIN-14, HIBC, or ISBT 128 DI |
| Brand Name / Device Description | Mandatory | Commercial product name |
| FDA Listing Number / Premarket Submission | Conditional | 510(k), PMA, or De Novo number |

## Standard JSON Response Model
```json
{
  "gudidValidation": "PASS",
  "primaryDi": "00884838012345",
  "deviceDescription": "Titanium Orthopedic Bone Screw 4.5mm"
}
```

## Frequently Asked Questions & Edge Cases
### Q: What premaket submissions require GUDID entry?
**A:** All Class I, Class II, and Class III medical devices marketed in the US require GUDID registration.