Exemptions from Reporting Requirements for Limited Production of Sunlamp Products for Commercial Use
This guidance outlines exemptions from reporting and recordkeeping requirements for manufacturers of sunlamp products (including tanning booths) who produce a limited number of units for their own commercial use.
Recommended Actions
- Determine the number of sunlamp products intended for manufacture
- If manufacturing less than 10 units:
- Submit notification to Director, Division of Compliance
- Include manufacturing location details
- If manufacturing more than 10 units:
- Prepare written exemption application
- Include production quantity and timeline
- Maintain compliance with performance standard requirements regardless of exemption status
- Prepare for potential FDA product inspections
- Keep track of total units manufactured to ensure staying within exemption limits
Key Considerations
Safety
- Products must comply with performance standard 21 CFR 1040.20 for sunlamp products
- FDA maintains ability to determine compliance through product inspections
Other considerations
- Automatic exemption applies to manufacturers producing less than 10 sunlamp products for own commercial use
- Manufacturers must notify the Director, Division of Compliance about:
- Number of products being manufactured (less than 10)
- Name and address of manufacturing location
- Manufacturers planning to produce more than 10 units must:
- 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
- Compatibility Criteria for Replacement UV Lamps in Sunlamp Products
Related references and norms
- 21 CFR 1040.20: Performance Standard for Sunlamp Products
- 21 CFR 1002: Records and Reports
Original guidance
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