Non-Clinical Testing Recommendations for Weight Loss and Obesity Treatment Devices (DRAFT)
This guidance covers medical devices with indications for weight loss, weight reduction, weight management, or obesity treatment in patients who are overweight or have obesity. It specifically addresses non-clinical testing recommendations for premarket submissions (PMA, IDE, 510(k), De Novo) for these devices.
This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What are the key non-clinical testing requirements for weight loss medical devices?
Non-clinical testing includes biocompatibility, sterility/pyrogenicity, shelf life validation, bench performance testing (corrosion, durability, fatigue), electrical safety, EMC testing, and potentially animal studies. Testing requirements vary based on device design, materials, and intended use duration.
How should manufacturers address MR safety for implantable weight loss devices?
Follow FDA guidance “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance Environment.” Include standardized terminology from ASTM F2503, conduct appropriate MR compatibility testing, and provide clear labeling with MR Conditional icons and safety conditions.
What biocompatibility considerations apply to intragastric devices with fill fluids?
Provide toxicological risk assessment of fill gas/liquid when expelled into stomach, evaluate chemical reactions between fill material and device, conduct leachable/extractable analysis, and ensure fill fluid is sterile to prevent hyperinflation from microbial contamination.
Are animal studies required for all weight loss medical devices?
Not necessarily. Animal studies are recommended when bench testing cannot adequately evaluate safety concerns. FDA supports the “3Rs” principles and encourages consultation via Q-Submission Program to determine if non-animal testing methods are suitable alternatives.
What specific labeling requirements exist for liquid-filled intragastric balloons?
Include FDA-identified risks (spontaneous hyperinflation, acute pancreatitis, perforations, aspiration, death) with occurrence rates separated by U.S. and global data. Provide comprehensive patient labeling including implant cards with MR safety information if applicable.
How should software documentation be handled for digital weight loss devices?
Follow FDA guidance “Content of Premarket Submissions for Device Software Functions.” Provide documentation commensurate with appropriate Documentation Level, include cybersecurity information for cyber devices, and address off-the-shelf software components with additional documentation requirements.
What You Need to Do 👇
Recommended Actions
- Determine appropriate documentation level for software based on risk assessment
- Develop comprehensive test plan covering all applicable non-clinical testing requirements
- Establish and justify acceptance criteria for all testing based on intended use
- Consider using Q-Submission Program to get FDA feedback on testing protocols
- Prepare detailed test reports following FDA’s recommended format
- Validate shelf life and packaging through appropriate testing
- Conduct animal studies if bench testing cannot adequately address safety concerns
- Develop comprehensive labeling addressing all required elements
- Validate sterilization processes if applicable
- Assess need for biocompatibility testing based on patient contact
Key Considerations
Non-clinical testing
- Dimensional verification to ensure proper device sizing and placement
- Strength testing for bonded/welded materials
- Durability and fatigue testing to maintain integrity throughout use duration
- Delivery/removal system testing to ensure safe and reliable placement/removal
- Testing for interactions with other medical devices if applicable
- Microorganism susceptibility testing for intragastric implants
Software
- Documentation level based on possible consequences of software failure
- Full description of software/firmware supporting device operation
- Cybersecurity documentation if device meets cyber device definition
- Additional documentation for off-the-shelf software if used
Cybersecurity
- Required documentation under section 524B(b) of the FD&C Act for cyber devices
- Assessment of potential interactions with other electronic medical devices
Labelling
- Warnings regarding nickel allergy for nitinol devices
- MR safety information and standardized terminology/icons
- Overview of clinical studies
- Adverse events information
- Patient labeling including implant card if applicable
Biocompatibility
- Assessment for all patient-contacting components
- Additional testing for devices with electrical components or dissimilar metals
- Metal ion release testing if corrosion resistance criteria not met
- Special considerations for nitinol-containing devices
Safety
- Electrical safety testing for electrical devices
- Electromagnetic compatibility testing
- Sterility validation for sterile devices
- Pyrogenicity testing as applicable
- Corrosion resistance testing for metallic devices
Other considerations
- Animal studies when bench testing is insufficient
- Shelf life and packaging validation
- Wireless technology testing if applicable
- MR compatibility testing for implants
Relevant Guidances đź”—
- Content of Premarket Submissions for Device Software Functions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Testing and Labeling of Medical Devices for Magnetic Resonance (MR) Environment Safety and Compatibility
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development
Related references and norms đź“‚
- AAMI/ANSI ES60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- AAMI/ANSI/IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances
- ISO 14708-3: Implants for Surgery – Active implantable medical devices – Part 3: Implantable neurostimulators
- ASTM F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
- AAMI/ANSI/ISO 11607-1: Packaging for terminally sterilized medical devices
- ASTM F2129: Standard test method for conducting cyclic potentiodynamic polarization measurements
- ASTM F3044: Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
- ASTM F3306: Standard Test Method for Ion Release Evaluation of Medical Implants