Direct Marking of Devices with Unique Device Identification (UDI) Requirements for Reusable Medical Devices

Recommended Actions

1. Determine if your device requires direct marking based on intended use and reprocessing requirements
2. Choose appropriate direct marking method considering:
   • Device characteristics
   • Expected service life
   • Reprocessing methods
   • Technological feasibility
3. Document in DHF:
   • Testing/analysis of marking impact on safety/effectiveness
   • Rationale for exceptions if applicable
   • Marking method selection justification
4. Submit required GUDID data:
   • Primary DI
   • Direct mark DI if different
   • Exception status if applicable
5. Maintain records showing:
   • All UDIs used
   • Direct marking status
   • DI/PI changes
   • Exception justifications
6. Ensure compliance with applicable deadlines based on device class
7. Consider requesting FDA review if marking affects safety/effectiveness through appropriate submission pathway (510(k), PMA, etc.)

Key Considerations

Non-clinical testing

• Testing should be conducted to determine the effect of direct marking on device safety and effectiveness
• Results should be documented in the Design History File (DHF)

Labelling

• The UDI direct mark must include both device identifier (DI) and production identifier (PI) portions
• The direct mark UDI can be identical to or different from the UDI on the device label
• The direct mark can be in either easily readable plain-text or AIDC format, or both

Safety

• If any type of direct marking would interfere with safety or effectiveness, the device qualifies for exception under 21 CFR 801.45(d)(1)
• The direct mark UDI must last throughout the expected service life of the device

Other considerations

• Applies to devices intended for repeated uses on different patients
• Requires high-level disinfection and/or sterilization before each use
• Compliance dates vary by device class (2015-2020)
• GUDID data submission required if direct marking DI differs from primary DI
• Recordkeeping requirements apply to all UDIs including direct marks

  Relevant Guidances

• Global Unique Device Identification Database (GUDID) Data Submission and Management Requirements
• Unique Device Identifier (UDI) Form and Content Requirements
• Unique Device Identification System: Implementation and Compliance Requirements
• Design Controls for Medical Device Manufacturers

Related references and norms

• 21 CFR 801.45: Direct marking requirements
• 21 CFR 820.30: Design controls
• 21 CFR 830.310: GUDID submission requirements

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Original guidance

• Direct Marking of Devices with Unique Device Identification (UDI) Requirements for Reusable Medical Devices
• HTML / PDF
• Issue date: 2017-11-17
• Last changed date: 2021-07-15
• Status: FINAL
• Official FDA topics: Medical Devices, UDI, Labeling, Biologics
• ReguVirta summary file ID: 42ed64b5ac2b08f1d2619860f7764c8e