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Technical Considerations for Photobiomodulation Devices in 510k Submissions (DRAFT)

This guidance provides recommendations for 510(k) submissions for photobiomodulation (PBM) devices, also known as low level light therapy (LLLT) devices, intended for aesthetic, dermatological, and general indications. It covers class II PBM medical devices regulated under specific CFR sections and product codes, including devices that combine PBM with other technologies.

This is a draft guidance. Not for implementation.

  1. Determine if clinical studies are needed based on device characteristics and claims
  2. Develop comprehensive test plan covering all safety aspects
  3. Prepare detailed device description including all technical parameters
  4. Establish biocompatibility evaluation strategy
  5. Create appropriate labeling with all required elements
  6. Implement necessary safety features and controls
  7. For OTC devices, plan and conduct usability studies
  8. Document software validation and verification
  9. Prepare performance testing data for 510(k) submission
  10. Consider early FDA feedback through Q-submission process

Key Considerations

Clinical testing

  • Clinical studies needed when non-clinical evaluation doesn’t fully characterize outcomes and risks
  • Study objectives should support device performance for proposed indications
  • Include control arms to distinguish device effects from background effects
  • Consider appropriate inclusion/exclusion criteria
  • Define clear study endpoints and success criteria
  • Determine appropriate study duration and follow-up schedule
  • Include statistical analysis plan
  • Monitor and report all adverse events

Non-clinical testing

  • Measure energy and irradiance output values
  • Validate device performance in intended use environment
  • Test thermal safety to demonstrate no tissue damage
  • Validate electromagnetic compatibility and electrical safety

Human Factors

  • For OTC devices, conduct three usability studies:
    • Self-selection study
    • Safe use study
    • Label comprehension study
  • Test with representative intended use population
  • Validate final labeling version

Software

  • Provide documentation based on level of concern (minor or moderate)
  • Include full description of software/firmware operation
  • Validate and verify software changes
  • Address cybersecurity aspects if applicable

Cybersecurity

  • Follow FDA guidance on cybersecurity management
  • Consider additional requirements for networked devices
  • Address security for wireless technology if applicable

Labelling

  • Include clear indications for use
  • Provide warnings and precautions
  • Detail treatment parameters and regimen
  • Include clinical study results overview if applicable
  • Provide reprocessing instructions if applicable

Biocompatibility

  • Evaluate all patient-contacting materials
  • Follow ISO 10993-1 recommendations
  • Address cytotoxicity, sensitization, and irritation endpoints

Safety

  • Implement eye safety measures
  • Include thermal safety controls
  • Ensure electrical safety
  • Validate electromagnetic compatibility
  • Address wireless technology safety if applicable

Other considerations

  • ANSI/AAMI ES 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • ANSI/AAMI IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility
  • ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

Original guidance

  • Technical Considerations for Photobiomodulation Devices in 510k Submissions
  • HTML / PDF
  • Issue date: 2023-01-12
  • Last changed date: 2023-01-11
  • Status: DRAFT
  • Official FDA topics: Medical Devices
  • ReguVirta summary file ID: 57d405a3e34022193d10399ecae6e426
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