Healthcare & Pharma

FDA UDI 요구사항: 바코드 규정 준수 가이드

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Everything medical device manufacturers need to know about FDA Unique Device Identification — GUDID registration, label requirements, and compliance dates.

  
  

    
  








  
  

    
    
      
      
  1. 
        FDA UDI Requirements: A Barcode Compliance Guide
      
    2. 
      
      
  2. 
        What UDI Requires
      
    3. 
      
      
  3. 
        Barcode Encoding
      
    4. 
      
      
  4. 
        Device Classification and Compliance Dates
      
    5. 
      
      
  5. 
        GUDID Registration
      
    6. 
      
      
  6. 
        Production Identifier Requirements
      
    7. 
      
      
  7. 
        Direct Part Marking
      
    8. 
      
      
  8. 
        Common Compliance Issues
      
    9. 
      
      
  9. 
        Implementation Steps
      
    10. 
      
    

  









  
  

  
  

    
    

      
FDA UDI Requirements: A Barcode Compliance Guide


The FDA's Unique Device Identification (UDI) system requires that most medical devices distributed in the US carry a barcode with standardized identification data. This guide covers the requirements for manufacturers.


What UDI Requires


Every medical device label must include:


    

  1. Device Identifier (DI): A unique code identifying the device model, assigned by an FDA-accredited issuing agency (GS1, HIBCC, or ICCBBA)
    2. 

  2. Production Identifier (PI): Variable data including lot number, serial number, expiration date, and manufacturing date (where applicable)
    3. 

  3. GUDID registration: DI and associated device information submitted to the Global Unique Device Identification Database
    4. 



Barcode Encoding


UDI data is encoded using:


    

  • GS1 DataMatrix: Preferred for small devices and packages
    • 

  • GS1-128: Used on larger packages and case labels
    • 

  • HIBCC codes: Alternative issuing agency format
    • 



Data Matrix with GS1 AIs for pharma and food traceability." data-category="2D & Matrix Symbologies">GS1 DataMatrix example:


(01)00860001234567(17)260630(10)LOT123(21)SER456
     DI (GTIN)        Expiry     Lot        Serial



Device Classification and Compliance Dates






Device Class
Risk Level
UDI Label
UDI on Device
GUDID






Class III
High (implants, life-sustaining)
Required
Required
Required




Class II
Moderate (surgical instruments)
Required
Required
Required




Class I
Low (tongue depressors, bandages)
Required
Case-by-case
Required






GUDID Registration


Manufacturers must submit device information to GUDID including:


    

  • Device identifier (DI)
    • 

  • Brand name and model number
    • 

  • Device description
    • 

  • Company name and contact
    • 

  • FDA product codes
    • 

  • Device characteristics (sterile, latex, MRI safe, etc.)
    • 

  • Package contents and configurations
    • 



Production Identifier Requirements


Which PI elements are required depends on the device:






PI Element
When Required






Lot/batch number
If the device is produced in lots




Serial number
If the device is individually serialized




Expiration date
If the device has a shelf life




Manufacturing date
If the device does not have an expiration date




Distinct identification code
For HCT/P regulated devices






Direct Part Marking


Implantable devices must carry UDI marking directly on the device itself (not just the label). Methods include:



The marking must survive the device's intended lifecycle, including sterilization cycles.


Common Compliance Issues


    

  • Missing or incorrect check digits in GTINs
    • 

  • Expiration dates in wrong format (must be YYMMDD)
    • 

  • Barcode quality below minimum grade
    • 

  • GUDID data not matching label information
    • 

  • PI data missing when required by device class
    • 



Implementation Steps


    

  1. Register with GS1 (or HIBCC) as an issuing agency
    2. 

  2. Assign DIs (GTINs) to every device version
    3. 

  3. Design labels with UDI barcodes meeting print quality standards
    4. 

  4. Register devices in GUDID
    5. 

  5. Verify barcode quality with an ISO/IEC-compliant verifier
    6. 

  6. Implement production line systems for serialization (if required)
    7.