Mouse Embryo Assay Testing for Assisted Reproduction Technology Devices
This guidance outlines recommendations for conducting Mouse Embryo Assay (MEA) testing for Assisted Reproduction Technology (ART) devices that have direct or indirect contact with gametes and/or embryos. It specifically applies to devices regulated under 21 CFR part 884 and excludes devices that only contact sperm.
Recommended Actions
- Develop MEA testing protocol according to device type and intended use
- Validate mouse strain selection and justify embryo culture conditions
- Implement appropriate test article preparation methods
- Establish quality control procedures for testing
- Document test results in accordance with FDA’s recommended format
- Update device labeling to include MEA acceptance criteria
- Develop Certificate of Analysis template including MEA results
- Establish shelf-life testing protocol including MEA
- Create procedures for lot release testing incorporating MEA requirements
- Maintain records of all MEA testing for regulatory compliance
Key Considerations
Non-clinical testing
- MEA testing should be conducted on devices in their final finished form
- Minimum of three individual devices should be evaluated in each test
- Testing should be performed at time zero and end of shelf-life
- One-cell or two-cell embryos should be obtained from hybrid mouse strains
- Minimum of 21 embryos for test article and 15 embryos for control medium
- Test duration: 96 hours for one-cell system or 72 hours for two-cell system
- Acceptance criteria: ≥80% embryos developed to expanded blastocyst
Labelling
- Package and vial labels should state the MEA acceptance criterion used
- Instructions for use should include MEA acceptance criterion
- Certificate of Analysis should state MEA acceptance criterion and lot-specific pass/fail results
Biocompatibility
- Test articles should be prepared according to device type (liquid-based, oil, plates/dishes, solid devices)
- Extraction conditions should follow ISO 10993-12 guidelines
- Culture media and labware should be intended for ART procedures
Other considerations
- Culture conditions should be maintained at 37°C and 5% CO2
- Test reports should follow FDA’s guidance for non-clinical bench performance testing
- Special considerations for different device types (one-step medium, culture oil, sequential solutions)
Relevant Guidances
- Bayesian Statistics in Medical Device Clinical Trials: Design, Analysis and Implementation
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
- Shelf Life and Stability Testing for Medical Devices
Related references and norms
- ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ISO 10993-12: Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
Original guidance
- Mouse Embryo Assay Testing for Assisted Reproduction Technology Devices
- HTML / PDF
- Issue date: 2021-01-05
- Last changed date: 2021-01-04
- Status: FINAL
- Official FDA topics: Medical Devices, Obstetrical & Gynecological, Premarket Approval (PMA), 510(k), Premarket, Investigational Device Exemption (IDE)
- ReguVirta summary file ID: bf33020bc72c17ff431553418695f6db
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