Post

Preparation of IDE Applications for Spinal Systems: Pedicle Screws, Intervertebral Body Fusion, Vertebral Body Replacement, and Disc Replacement Devices

This guidance provides recommendations for the preparation of Investigational Device Exemption (IDE) applications for spinal systems, including pedicle screw systems, intervertebral body fusion devices, vertebral body replacement devices, and vertebral disc replacements. It outlines the necessary preclinical and clinical information required to demonstrate reasonable assurance of safety and effectiveness.

  1. Develop comprehensive preclinical testing plan including mechanical testing and animal studies if needed
  2. Design clinical study protocol with:
    • Clear inclusion/exclusion criteria
    • Appropriate control group
    • Minimum 2-year follow-up
    • Validated assessment tools
    • Defined success criteria
  3. Prepare complete device description documentation including:
    • Component descriptions and drawings
    • Materials information
    • Manufacturing processes
    • Sterilization validation
  4. Develop risk management documentation:
    • Comprehensive risk analysis
    • Risk mitigation strategies
    • Adverse event monitoring plan
  5. Create labeling package:
    • Package labels
    • Package insert
    • Surgical technique manual
  6. Establish monitoring procedures and investigator requirements
  7. Consider early consultation with FDA, especially regarding:
    • Mechanical testing requirements
    • Animal study design
    • Clinical protocol design
    • Success criteria
  8. Prepare statistical analysis plan including sample size justification
  9. Develop retrieval study protocol for removed devices
  10. Ensure compliance with biocompatibility requirements based on materials used

Key Considerations

Clinical testing

  • Minimum 2 years follow-up data required
  • Primary evaluation parameters: radiographic success, pain assessment, functional assessment
  • Secondary parameters: donor site pain, disc/vertebral height assessment, quality of life
  • Clear success criteria needed for both patient and study level
  • Comprehensive neurological evaluation required
  • Detailed tracking of complications and subsequent surgical interventions

Non-clinical testing

  • Complete mechanical testing reports required (static and fatigue testing)
  • Animal studies may be needed for:
    • Biologic response evaluation
    • Dosing studies
    • Functional studies
    • Novel designs validation
  • Rationale needed if testing is not performed

Human Factors

  • Surgical technique manual required
  • Post-operative regimen must be detailed
  • Training requirements for investigators must be specified

Labeling

  • Package labels must include:
    • Device name and quantity
    • Material information
    • Sterility status
    • Manufacturer details
    • Investigational device caution statement
  • Package insert required with:
    • Device description
    • Inclusion criteria
    • Contraindications/warnings
    • Potential adverse events
  • Surgical technique manual required

Biocompatibility

  • Testing required based on materials used
  • Must comply with AAMI/ANSI 10993-1
  • Additional requirements for biological/drug components

Safety

  • Comprehensive risk analysis required
  • All adverse events must be recorded and reported
  • Subsequent surgical interventions must be tracked
  • Neurological status must be monitored
  • Retrieval study recommended for removed devices

Other considerations

  • ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
  • AAMI/ANSI 10993-1: Biological evaluation of medical devices

Original guidance

  • Preparation of IDE Applications for Spinal Systems: Pedicle Screws, Intervertebral Body Fusion, Vertebral Body Replacement, and Disc Replacement Devices
  • HTML / PDF
  • Issue date: 2000-01-12
  • Last changed date: 2024-04-11
  • Status: FINAL
  • Official FDA topics: Medical Devices, Labeling, Pediatric Product Development
  • ReguVirta summary file ID: 8b05e9a963e655a3de019c6450376e84
This post is licensed under CC BY 4.0 by the author.