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Technical Considerations for Pen, Jet, and Related Injectors Submitted in Drug and Biological Product Applications

This guidance describes the technical and scientific information expected in marketing applications for pen, jet, or related injector devices intended for use with drugs or biological products. It covers general use injectors, injectors for specific drug/biological product classes/families, and injectors for specific drug/biological products.

  1. Determine the regulatory pathway based on intended use (510(k) vs NDA/BLA)
  2. Conduct comprehensive design verification testing:
    • Performance testing
    • Biocompatibility
    • Stability/shelf-life
    • Human factors validation
  3. Develop complete documentation package including:
    • Device description and specifications
    • Test protocols and reports
    • Risk analysis
    • Labeling
  4. Consider early interactions with FDA through pre-submission meetings
  5. Ensure sterilization validation and sterility assurance
  6. Develop appropriate labeling for intended users
  7. Validate manufacturing processes and quality systems
  8. Address any drug-device compatibility issues
  9. Consider need for clinical data based on risk assessment
  10. Prepare marketing application according to appropriate format (510(k) or CTD)

Key Considerations

Clinical testing

  • Human factors studies to evaluate user interactions and validate safe/effective use by intended population
  • Evaluation of user-related risks
  • Assessment of ability to read/understand instructions, setup injector, set proper dose, perform injection correctly
  • Additional in-use testing may be needed for critical features

Non-clinical testing

  • Performance testing for dose accuracy, depth and route of injection
  • Testing under environmental conditions (temperature, storage, shipping, etc.)
  • Functional testing (flow rate, injection time, reliability, safety features, etc.)
  • Mechanical specifications testing (assembly force, actuation force, etc.)
  • Shelf-life stability and expiration dating studies

Human Factors

  • Comprehensive evaluation of all user-related risks
  • Validation studies with representative users
  • Assessment of ability to read/understand instructions, setup, dose setting, injection technique
  • Consider user population characteristics (age, dexterity limitations, etc.)
  • Consider environment of use conditions

Labeling

  • Clear instructions for use appropriate for intended users
  • Description of injector and indications
  • Warnings, limitations, precautions
  • Assembly and operation instructions
  • Storage conditions and shelf-life
  • Disposal instructions
  • Patient labeling/medication guide as applicable

Biocompatibility

  • Testing per ISO 10993-1 for patient-contacting components
  • Evaluation of materials in fluid path
  • Assessment of extractables/leachables
  • Testing with actual drug/biological product

Safety

  • Sterilization validation
  • Assessment of cross-contamination risks for multi-patient devices
  • Testing of safety features and protections
  • Evaluation of sharps injury prevention features

Other considerations

  • ISO 7886-1: Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use
  • ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
  • ISO 11608-1: Pen-Injectors for Medical Use – Part 1: Requirements and test methods
  • ISO 11608-2: Pen-Injectors for Medical Use – Part 2: Needles – Requirements and test methods
  • ISO 11608-3: Pen-Injectors for Medical Use – Part 3: Finished Cartridges – Requirements and test methods
  • ISO 11608-4: Pen-Injectors for Medical Use – Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
  • ISO 21649: Needle-Free Injectors for Medical Use - Requirements and Test Methods
  • ASTM D4169: Standard Practice for Performance Testing of Shipping Containers and Systems

Original guidance

  • Technical Considerations for Pen, Jet, and Related Injectors Submitted in Drug and Biological Product Applications
  • HTML / PDF
  • Issue date: 2013-06-07
  • Last changed date: 2020-05-05
  • Status: FINAL
  • Official FDA topics: Medical Devices, Drugs, Combination Products, Biologics, Administrative / Procedural
  • ReguVirta summary file ID: 2068fa502397a2813489698f0a0da4f6
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