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.
What You Need to Know? 👇
What are the FDA reporting requirements for sunlamp product manufacturers?
Manufacturers must submit initial reports, annual reports, and model change reports to the FDA. They must also maintain quality control records, life testing results, and communications regarding radiation safety for 5 years.
Can small-scale sunlamp manufacturers get exemptions from FDA reporting requirements?
Yes, manufacturers producing fewer than 10 sunlamp products for their own commercial facilities can be exempted from reporting and recordkeeping requirements by notifying the FDA’s Division of Compliance.
What notification is required for the sunlamp manufacturing exemption?
Manufacturers must notify the Director of the Division of Compliance that they’re manufacturing less than 10 sunlamp products for personal use and provide the name and address of the manufacturing location.
Are there exemptions available for manufacturers producing more than 10 sunlamp products?
Manufacturers wanting to produce more than 10 units aren’t automatically exempt but can apply for exemption by submitting a written application detailing intended production numbers and timeframe to the Bureau of Radiological Health.
What regulatory authority allows FDA to grant sunlamp manufacturing exemptions?
The FDA grants these exemptions under the authority of 21 CFR 1002.50, which provides regulatory flexibility for specific circumstances while maintaining compliance oversight through product inspections.
Why did FDA create exemptions for small sunlamp manufacturers?
The Bureau found that full reporting and recordkeeping requirements were overly burdensome for individuals manufacturing small quantities infrequently for personal use, and exemptions don’t compromise safety since compliance can be verified through inspections.
What You Need to Do 👇
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:
- Submit written application for exemption
- State intended number of products
- Specify manufacturing time period
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
- 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