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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This is a draft guidance. Not for implementation.

  1. Determine appropriate documentation level for software based on risk assessment
  2. Develop comprehensive test plan covering all applicable non-clinical testing requirements
  3. Establish and justify acceptance criteria for all testing based on intended use
  4. Consider using Q-Submission Program to get FDA feedback on testing protocols
  5. Prepare detailed test reports following FDA’s recommended format
  6. Validate shelf life and packaging through appropriate testing
  7. Conduct animal studies if bench testing cannot adequately address safety concerns
  8. Develop comprehensive labeling addressing all required elements
  9. Validate sterilization processes if applicable
  10. 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

  • 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

Original guidance

  • Non-Clinical Testing Recommendations for Weight Loss and Obesity Treatment Devices
  • HTML / PDF
  • Issue date: 2023-09-15
  • Last changed date: 2023-09-14
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Gastroenterology-Urology, Premarket
  • ReguVirta summary file ID: 806dc36afd7983fe9638e3958ae07d8b
This post is licensed under CC BY 4.0 by the author.