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.
What You Need to Know? 👇
What are the key phases required for evaluating hysteroscopic sterilization devices according to FDA guidelines?
The evaluation follows four phases: Phase I (preclinical studies including device description, physical properties, and animal studies), Phase II (investigational clinical studies), Phase III (expanded clinical trials), and Phase IV (post-marketing surveillance for long-term safety and efficacy monitoring).
What animal models are recommended for preclinical testing of hysteroscopic sterilization devices?
Monkeys are recommended for general studies, with baboons specifically recommended for tubal plug systems. Animal studies must evaluate tissue fibrosis, chemical leaching, migration, effects on myometrial tissue, and menstrual history changes before clinical testing begins.
What informed consent requirements must be met for hysteroscopic sterilization device clinical trials?
Patients must be informed about: benefits/risks of alternative sterilization methods, specific risks of hysteroscopic sterilization, the experimental nature of the procedure, pregnancy possibilities, potential need for device removal, and requirement for unlimited follow-up communication with investigators.
How is tubal occlusion assessed in hysteroscopic sterilization device studies?
Tubal occlusion is determined using hysterosalpingogram following WHO standards. The test requires maintaining 150 mm Hg pressure for one minute. This assessment is performed at three months post-procedure during Phase II feasibility trials.
What post-marketing surveillance requirements exist for hysteroscopic sterilization devices?
Manufacturers must maintain distribution records, establish adverse reaction reporting systems, follow 2000+ cases for minimum five years, track pregnancy rates beyond two years, and provide quarterly distribution numbers to FDA for potential recalls or safety warnings.
What minimum sample sizes are required for different phases of hysteroscopic sterilization device clinical studies?
Phase II requires minimum 5 patients for hysterectomy studies and 50 cases for preliminary feasibility trials. Phase III expanded trials require additional 2000 cases followed for minimum five years across multiple medical centers.
What You Need to Do 👇
Recommended Actions
- Develop comprehensive preclinical testing plan including physical properties and animal studies
- Prepare detailed device and technique description documentation
- Establish sterilization validation protocol
- Design Phase II clinical study protocol with minimum 50 cases
- Develop patient informed consent documentation
- Create post-marketing surveillance plan
- Establish adverse reaction reporting system
- Implement distribution tracking system
- Prepare long-term follow-up protocol for minimum 5 years
- Create documentation system for device traceability
- Establish quality control measures for manufacturing
- Develop physician training program
- 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
- Post-marketing surveillance requirements
- Record keeping of device distribution
- Adverse reaction reporting system
- Long-term pathological and efficacy data collection
- Manufacturer responsibility for maintaining records
Relevant Guidances 🔗
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Benefit-Risk Determinations for Medical Device Premarket Review
- Postmarket Surveillance Studies Requirements for Medical Devices Under Section 522