home / skills / a5c-ai / babysitter / udi-labeling-generator

udi-labeling-generator skill

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This skill helps generate compliant UDI labels and manage device identifiers for FDA GUDID and EU EUDAMED submissions.

npx playbooks add skill a5c-ai/babysitter --skill udi-labeling-generator

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SKILL.md

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---
name: udi-labeling-generator
description: Unique Device Identification (UDI) and labeling compliance skill for generating compliant labels and device identifiers
allowed-tools:
  - Read
  - Write
  - Glob
  - Grep
  - Edit
  - Bash
metadata:
  specialization: biomedical-engineering
  domain: science
  category: Regulatory Compliance
  skill-id: BME-SK-004
---

# UDI Labeling Generator Skill

## Purpose

The UDI Labeling Generator Skill creates compliant Unique Device Identification labels and manages device identifier assignments for FDA GUDID and EU EUDAMED submissions.

## Capabilities

- UDI-DI and UDI-PI generation
- GUDID data submission preparation
- Label content validation
- IFU (Instructions for Use) template generation
- Multi-language labeling support
- Symbol compliance verification (ISO 15223-1)
- Barcode generation (GS1, HIBCC, ICCBBA)
- Label artwork review assistance
- EUDAMED UDI registration support
- Package hierarchy management
- Date format standardization

## Usage Guidelines

### When to Use
- Creating device labeling for regulatory submission
- Registering devices in GUDID or EUDAMED
- Designing label artwork and content
- Validating labeling compliance

### Prerequisites
- Device identification information finalized
- Issuing agency account established
- Package configuration defined
- Regulatory requirements identified

### Best Practices
- Establish UDI strategy early in development
- Validate barcode readability across packaging
- Ensure symbol usage meets ISO 15223-1
- Maintain consistency across label variants

## Process Integration

This skill integrates with the following processes:
- 510(k) Premarket Submission Preparation
- EU MDR Technical Documentation
- Design Control Process Implementation
- Sterile Barrier System Validation

## Dependencies

- FDA GUDID API
- GS1 standards and databases
- EUDAMED system
- ISO 15223-1 symbol library
- Issuing agency interfaces

## Configuration

```yaml
udi-labeling-generator:
  issuing-agencies:
    - GS1
    - HIBCC
    - ICCBBA
  label-types:
    - device-label
    - package-label
    - shipping-label
  barcode-formats:
    - GS1-128
    - DataMatrix
    - QR-Code
  regulatory-regions:
    - FDA
    - EU-MDR
    - Health-Canada
```

## Output Artifacts

- UDI-DI assignments
- UDI-PI format specifications
- GUDID submission files
- Label content templates
- IFU drafts
- Barcode specifications
- Symbol usage guides
- Multi-language label sets

## Quality Criteria

- UDI format complies with issuing agency requirements
- Labels meet FDA 21 CFR 801 requirements
- EU MDR Annex VI requirements satisfied
- Symbols conform to ISO 15223-1
- Barcodes meet readability specifications
- Package hierarchy accurately represented

Overview

This skill generates compliant Unique Device Identification (UDI) labels and manages device identifier assignments for regulatory submissions. It streamlines UDI-DI and UDI-PI creation, barcode generation, and label content validation across FDA (GUDID), EU (EUDAMED), and other jurisdictions. The result is ready-to-submit artifacts and reusable label templates for production and regulatory workflows.

How this skill works

The skill validates device and package data, selects the correct issuing agency format (GS1, HIBCC, ICCBBA), and constructs UDI-DI and UDI-PI strings that meet agency rules. It produces barcode outputs (GS1-128, DataMatrix, QR) and verifies symbol usage against ISO 15223-1. It can generate GUDID/EUDAMED submission files, IFU templates, and multi-language label sets, and it flags noncompliant elements for correction.

When to use it

Preparing device labels for regulatory submission (GUDID, EUDAMED)
Assigning UDI-DI/UDI-PI during product launch or design transfer
Designing or reviewing label artwork and packaging hierarchy
Validating barcode readability and symbol compliance before production
Generating IFU drafts and multi-language label sets for distribution

Best practices

Define your UDI strategy and issuing agency early in development
Lock device identification data and package configuration before label generation
Validate barcodes with the intended printing substrate and scanner hardware
Ensure symbol selection and placement follow ISO 15223-1 and regional requirements
Keep label variants and translations synchronized with a single source of truth

Example use cases

Create UDI-DI assignments and export GUDID submission files for a new 510(k) device
Generate multi-level packaging labels with GS1 DataMatrix barcodes for shipment and inventory
Produce IFU templates and symbol usage guides for inclusion in Technical Documentation under EU MDR
Run pre-production label audits to confirm barcode readability and regulatory text formatting
Prepare EUDAMED-ready registration artifacts and packaging hierarchy maps for a product family

FAQ

Which issuing agencies does the skill support?

It supports GS1, HIBCC, and ICCBBA formats and can be configured to produce the appropriate identifiers and barcode symbologies.

Can it produce files ready for GUDID or EUDAMED submission?

Yes. The skill prepares GUDID and EUDAMED data exports and validates required fields and formats to reduce submission rework.