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This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What are the key technical parameters that must be characterized for PBM devices in 510(k) submissions?
The guidance requires characterization of wavelength (in nm), energy fluence (J/m² or mJ/cm²), spot size (mm), output mode (pulsed/CW), radiant power and irradiance (W/m² or mW/cm²), and for pulsed devices: pulse duration, energy per pulse, duty cycle, and repetition rate.
When are clinical studies required for PBM device 510(k) submissions?
Clinical studies are recommended when non-clinical evaluation doesn’t fully characterize clinical experience, outcomes, and risks. Changes in indications for use, output parameters, or treatment regimen compared to predicate devices may warrant clinical studies to assess safety and effectiveness.
What biocompatibility testing is typically required for PBM devices?
PBM devices are typically considered surface devices with limited contact duration (<24 hours) with intact skin. The recommended biocompatibility endpoints are cytotoxicity, sensitization, and irritation or intracutaneous reactivity, following ISO 10993-1 guidance.
What usability studies are recommended for over-the-counter PBM devices?
Three usability studies are recommended: 1) demonstrating lay users can correctly self-select as appropriate users by reading box labeling, 2) showing users can safely use the device following instructions, and 3) assessing understanding of patient labeling including indications, contraindications, warnings, and precautions.
What software documentation level is typically required for PBM devices?
FDA generally considers PBM device software to present “minor” or “moderate” level of concern. Devices with simple on/off and timer functions may be “minor,” while those controlling treatment parameters are typically “moderate.” Documentation should follow FDA software guidance commensurate with the appropriate concern level.
What modifications to PBM devices typically require a new 510(k) submission?
Changes requiring new 510(k)s include: modifications to light source, circuitry, or power supply; changes in light output or treatment regimen; and switching from prescription to OTC use. These changes could significantly affect device safety or effectiveness by altering tissue effects or use environment.
What You Need to Do 👇
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 đź”—
- 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 đź“‚
- 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