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Clinical and Non-Clinical Testing Requirements for Hysteroscopic Sterilization Devices

This guidance provides guidelines for evaluating hysteroscopic sterilization devices, covering different modalities including tubal blockage, implants, chemical injury techniques, and physical injury techniques. It outlines requirements for preclinical and clinical investigations to assess safety, effectiveness in preventing pregnancy, and associated risks.

  1. Develop comprehensive preclinical testing plan including physical properties and animal studies
  2. Prepare detailed device and technique description documentation
  3. Establish sterilization validation protocol
  4. Design Phase II clinical study protocol with minimum 50 cases
  5. Develop patient informed consent documentation
  6. Create post-marketing surveillance plan
  7. Establish adverse reaction reporting system
  8. Implement distribution tracking system
  9. Prepare long-term follow-up protocol for minimum 5 years
  10. Create documentation system for device traceability
  11. Establish quality control measures for manufacturing
  12. Develop physician training program
  13. Create protocol for hysterosalpingogram testing at 3 months

Key Considerations

Clinical testing

  • Initial clinical trial (Phase II) with minimum 50 cases and 5 investigators
  • Three-month follow-up with hysterosalpingogram to determine tubal occlusion
  • Minimum one-year follow-up for initial cases
  • Phase III expanded trial with 2000 cases followed for minimum 5 years
  • Patient informed consent requirements
  • WHO standard for hysterosalpingograms (150 mm Hz pressure held for one minute)

Non-clinical testing

  • Engineering tests for physical properties
  • Stability testing in biological environment
  • Testing on extirpated human uteri specimens
  • Animal studies (preferably baboons for tubal plug systems)
  • X-ray studies
  • Pathological studies

Human Factors

  • Documentation of cleaning and maintenance procedures
  • Ease of application assessment
  • Packaging should allow easy removal and preparation without contamination

Labelling

  • Detailed information for informed consent
  • Information about risks and benefits
  • Clear indication of experimental nature
  • Information about alternative sterilization methods

Biocompatibility

  • Toxicity testing for new materials
  • Local tissue reaction assessment
  • Stability in biological environment evaluation
  • Response to body fluids examination

Safety

  • Documentation of sterilization process adequacy
  • Assessment of local tissue reactions
  • Evaluation of migration potential
  • Monitoring of adverse events
  • Assessment of effects on adjacent tissues

Other considerations


Original guidance

  • Clinical and Non-Clinical Testing Requirements for Hysteroscopic Sterilization Devices
  • HTML / PDF
  • Issue date: 1978-05-09
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 4568ebc776cae9420af4e4a111eec224
This post is licensed under CC BY 4.0 by the author.