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Premarket Notification Requirements for Healthcare Facility Sterilizers

This guidance provides direction for 510(k) submissions for sterilizers intended for use in healthcare facilities like hospitals, clinics, and healthcare professional offices. It excludes sterilizers used in manufacturing, ionizing radiation technologies, pre-cleaning devices, sterilization wraps, contact lens sterilizers, and liquid chemical sterilizers.

  1. Determine if sterilizer technology is traditional (steam, dry heat, EtO) or non-traditional as requirements differ
  2. Develop comprehensive test protocol including:
    • Biological performance testing
    • Material compatibility testing
    • Toxicity and residue testing
    • Process validation
  3. Prepare detailed device description and specifications
  4. Create comprehensive labeling package
  5. Conduct software validation if applicable
  6. Verify EPA requirements if using regulated sterilants
  7. Complete process validation with 3 consecutive successful runs
  8. Document all test results and analyses thoroughly
  9. Use provided checklist to ensure submission completeness
  10. Consider pre-submission meeting with FDA for new technologies

Key Considerations

Non-clinical testing

  • Must demonstrate sterilizer can achieve Sterility Assurance Level (SAL) of 10^-6 for all medical products listed in labeling
  • Requires biological performance testing including:
    • Sporicidal screening test (for non-traditional sterilizers)
    • D-value determination
    • Half cycle validation
    • Total kill endpoint validation
    • Simulated and in-use testing (for non-traditional sterilizers)

Software

  • Software documentation required per FDA Software Reviewer’s Guide
  • Sterilizers considered “moderate” risk category for software

Labeling

  • Must include device markings, information manual, and service manual
  • Information manual must detail:
    • Intended use and limitations
    • Installation and operating instructions
    • Error indications and responses
    • Monitoring instructions
    • Warnings and precautions

Biocompatibility

  • Must determine toxicity profile of sterilant and by-products
  • Must establish residue levels and procedures to reduce to acceptable levels
  • Material compatibility testing required for all claimed compatible materials

Safety

  • Must include safety features and controls
  • Must address toxic residues and by-products
  • Must include appropriate warnings and precautions in labeling

Other considerations

  • AAMI Sterilization Standards for steam and EtO
  • ISO 194: Biological evaluation of medical devices
  • ASTM standards for material testing

Original guidance

  • Premarket Notification Requirements for Healthcare Facility Sterilizers
  • HTML / PDF
  • Issue date: 1993-03-01
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket
  • ReguVirta summary file ID: 4635f6e9dae6a3cbbaf52d26ce11a820
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