Resorbable Adhesion Barrier Devices for Abdominal and Pelvic Surgery - Development and Testing Requirements
This guidance discusses the development of preclinical and clinical information required for Investigational Device Exemption (IDE), Premarket Approval (PMA), or Product Development Protocol (PDP) applications for resorbable adhesion barrier products used in abdominal and/or pelvic surgery. It specifically addresses devices that are resorbed within 30 days of placement into the peritoneal/pelvic cavity.
Recommended Actions
- Conduct comprehensive preclinical testing program including biocompatibility, animal studies, and bench testing
- Develop detailed manufacturing and sterilization processes
- Design randomized controlled clinical trial with clear endpoints
- Establish second-look assessment methodology
- Create comprehensive data collection tools and case report forms
- Develop detailed labeling including all required elements
- Prepare risk/benefit analysis based on all available data
- Consider need for post-approval studies
- Engage with FDA early in development process
- Ensure compliance with all applicable standards and regulations
Key Considerations
Clinical testing
- Randomized, concurrently-controlled pivotal trials are recommended
- Second-look surgery is primary modality for assessment
- Clear inclusion/exclusion criteria must be defined
- Both Intent-to-Treat and Evaluable patient populations should be analyzed
- Separate evaluation needed for laparotomy vs laparoscopic approaches
- Post-approval studies may be required for unresolved safety issues
Non-clinical testing
- Pharmacokinetics studies required to determine absorption, distribution, metabolism and excretion
- Effectiveness studies in appropriate animal models needed
- Physical/mechanical bench testing required
- Product stability and shelf-life data needed
Labeling
- Must include device description, indications, contraindications, warnings/precautions
- Adverse events must be clearly presented
- Clinical studies summary required
- Detailed instructions for use needed
- Investigational devices must be labeled according to 21 CFR 812.5
Biocompatibility
- Must follow ISO 10993-1 guidelines
- Six standard tests required: cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and subchronic implantation
- Additional testing may be needed based on material characteristics
Safety
- Complete toxicology/biocompatibility testing required before IDE submission
- Testing needed for delay/prevention of healing
- Infectivity testing required
- Reproductive/developmental toxicity studies needed in two species
- Carcinogenesis/metastasis effects must be evaluated
Other considerations
- Manufacturing process and controls must be described in detail
- Sterilization validation required with SAL of 10^-6
- Device must be characterized chemically and physically
- Risk/benefit analysis required
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Design Controls for Medical Device Manufacturers
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
- Benefit-Risk Determinations for Medical Device Premarket Review
Related references and norms
- ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
- ANSI/AAMI/ISO 10993-7: Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
Original guidance
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