Direct Marking of Devices with Unique Device Identification (UDI) Requirements for Reusable Medical Devices
This guidance clarifies FDA's requirements for direct marking of devices with Unique Device Identification (UDI). It applies to devices that must bear a UDI on their label and are intended to be used more than once and reprocessed before each use. The guidance defines key terms and provides interpretation of the UDI direct marking requirements.
What You Need to Know? 👇
What devices require UDI direct marking and when must they comply?
Devices intended for reuse and reprocessing must have UDI permanently marked on the device itself. Compliance dates vary: life-sustaining devices by 9/24/2015, Class III by 9/24/2016, Class II by 9/24/2018, and Class I by 9/24/2020.
Does adding UDI direct marking require new FDA submissions for approved devices?
Generally no, unless the marking interferes with safety or effectiveness. For 510(k) devices, new submission may be needed if marking significantly affects safety. For PMA/BLA devices, supplements are typically required only if marking affects safety/effectiveness.
What are the exceptions to UDI direct marking requirements?
Four exceptions exist: marking interferes with safety/effectiveness, not technologically feasible, single-use devices undergoing reprocessing, or devices previously marked. Labelers must document the basis for using exceptions in their design history file.
Can the direct mark UDI be different from the label UDI?
Yes. The direct mark UDI can be identical to or different from the label UDI. However, it must include the full UDI with all production identifiers, except when identifiers were unknown during manufacturing.
What does “intended to be reprocessed” mean for direct marking requirements?
Devices intended to undergo high-level disinfection and/or sterilization before each use or between uses. Devices requiring only cleaning or lower-level disinfection without subsequent high-level disinfection or sterilization are not subject to direct marking.
What marking methods are acceptable for UDI direct marking?
FDA doesn’t specify methods. Options include etching, permanent plaques, RFID tags, or durable stickers. The marking must last throughout the device’s expected service life considering usage and reprocessing according to manufacturer instructions.
What You Need to Do 👇
Recommended Actions
- Determine if your device requires direct marking based on intended use and reprocessing requirements
- Choose appropriate direct marking method considering:
- Device characteristics
- Expected service life
- Reprocessing methods
- Technological feasibility
- Document in DHF:
- Testing/analysis of marking impact on safety/effectiveness
- Rationale for exceptions if applicable
- Marking method selection justification
- Submit required GUDID data:
- Primary DI
- Direct mark DI if different
- Exception status if applicable
- Maintain records showing:
- All UDIs used
- Direct marking status
- DI/PI changes
- Exception justifications
- Ensure compliance with applicable deadlines based on device class
- 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