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This is a draft guidance. Not for implementation.
Recommended Actions
- Determine if clinical studies are needed based on device characteristics and claims
- Develop comprehensive test plan covering all safety aspects
- Prepare detailed device description including all technical parameters
- Establish biocompatibility evaluation strategy
- Create appropriate labeling with all required elements
- Implement necessary safety features and controls
- For OTC devices, plan and conduct usability studies
- Document software validation and verification
- Prepare performance testing data for 510(k) submission
- 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
- Describe device modifications requiring new 510(k)
- Detail anatomic areas of use
- Specify light generation method
- Define wavelength and energy parameters
- Provide spot size and output mode information
Relevant Guidances
- Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms
- 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
This post is licensed under CC BY 4.0 by the author.