Inspection and Field Testing Requirements for Sunlamp Products and UV-Emitting Devices
This guidance provides specific instructions for inspecting and field testing sunlamp products (tanning devices) that emit ultraviolet radiation. It covers both products manufactured before and after September 8, 1986, focusing on compliance with performance standards under 21 CFR 1040.20.
Recommended Actions
- Implement comprehensive inspection checklist covering all performance requirements
- Verify proper labeling and warning statements on all products
- Test timer accuracy and maximum interval settings
- Verify protective eyewear compliance with transmittance requirements
- Review user instructions for completeness and accuracy
- Check lamp compatibility and proper certification
- Verify proper positioning of measurement instruments during testing
- Document all inspection findings using provided checklist format
- Ensure proper classification of any non-compliant items
- Submit copies of manufacturer correspondence to HFZ-240
Key Considerations
Non-clinical testing
- Testing must account for errors and statistical uncertainties in radiation emission
- Measurements must be made under manufacturer-recommended operational conditions
- Measuring instruments must be positioned at recommended exposure position for maximum detection
Human Factors
- Products must incorporate proper user positioning instructions
- Clear instructions for determining exposure time based on skin type
- Instructions for proper operation of controls and timer must be provided
Labelling
- Must include warning statements about UV radiation dangers
- Must specify recommended exposure positions and schedule
- Must include lamp designation and model identification
- Labels must be permanently affixed and readily visible
- User instructions must include safety information and operational guidance
Safety
- Timer system with multiple settings required
- Maximum timer intervals must not exceed 3 times recommended exposure time
- Protective eyewear must meet specific transmittance requirements
- Must include control for termination of radiation emission
- UV lamps must have specific compatibility requirements
Other considerations
- Products must comply with irradiance ratio limits for UVC over UVB
- Specific requirements for lamp compatibility and replacement components
- Requirements for proper documentation and certification labeling
Relevant Guidances
- Applicability of Sunlamp Performance Standards to UVA Tanning Products (Revoked)
- Recordkeeping Requirements and Exemptions for Portable Home Sunlamp Products and UV Lamps
- Regulatory Requirements and Enforcement Actions for Defective Sunlamp Products Manufactured Before May 7, 1980
- Quality Control and Quality Assurance for Sunlamp Products and UV Lamps
- Exemptions from Reporting Requirements for Limited Production of Sunlamp Products for Commercial Use
Related references and norms
- 21 CFR 1040.20: Performance Standard for Sunlamp Products and Ultraviolet Lamps
- 21 CFR 1010.2: Certification
- 21 CFR 1010.3: Identification
- 21 CFR 1010.4: Variances
Original guidance
- Inspection and Field Testing Requirements for Sunlamp Products and UV-Emitting Devices
- HTML
- Issue date: 2007-10-30
- Last changed date: 2020-03-24
- Status: FINAL
- Official FDA topics: Medical Devices, Radiation-Emitting Products
- ReguVirta summary file ID: c240afb9fe5ae7bda93d1b796c70de12
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