Compatibility Criteria for Replacement UV Lamps in Sunlamp Products
This guidance outlines the criteria and policy for determining lamp compatibility for replacement ultraviolet lamps used in sunlamp products, as per the amended performance standard (21 CFR 1040.20).
What You Need to Know? 👇
What are the FDA requirements for sunlamp compatibility testing?
Replacement lamps must not cause sunlamp products to fail compliance standards and must be within ±10% effectiveness of the original lamp in causing erythema and melanogenesis, following specific CDRH calculation procedures.
When did the amended sunlamp performance standard become effective?
The amended performance standard for sunlamp products (21 CFR 1040.20) became effective on September 8, 1986, applying to all ultraviolet lamps and sunlamp products manufactured on or after that date.
What labeling requirements exist for replacement ultraviolet lamps?
User instructions for ultraviolet lamps not accompanying sunlamp products must clearly identify by brand name and model designation all lamp models for which replacement lamps are promoted, per 21 CFR 1040.20(f)(2)(iii).
How does FDA define lamp compatibility for sunlamp products?
A replacement lamp is compatible if it doesn’t cause the sunlamp product to fail compliance or become defective, and maintains effectiveness within ±10% of the original lamp for erythema and melanogenesis.
What happens if incompatible lamps are promoted for sunlamp products?
Promoting incompatible lamps is considered marketing a falsely certified product according to FDA policy, which can result in regulatory enforcement actions and compliance violations.
What calculation method should manufacturers use for lamp compatibility assessment?
Manufacturers should calculate recommended maximum exposure times for both original and replacement lamps using CDRH’s August 21, 1986 guidance, then compare values to ensure ±10% compatibility at typical use distances.
What You Need to Do 👇
Recommended Actions
- Establish a testing protocol to verify replacement lamp compatibility
- Document calculations of maximum exposure times for both original and replacement lamps
- Implement verification process to ensure replacement lamps are within ±10% effectiveness of original lamps
- Update user instructions to include clear identification of compatible lamp models
- Maintain documentation of compatibility testing and calculations
- Establish quality control measures to ensure ongoing compliance with safety requirements
- Review and update product labeling to reflect correct exposure schedules and timer intervals
- Implement a system to track and verify compatibility claims for all replacement lamps
Key Considerations
Non-clinical testing
- Replacement lamp must be tested to ensure it’s within ±10% effectiveness of the original lamp in causing erythema and melanogenesis
- Maximum exposure time calculations must be performed for both original and replacement lamps using CDRH guidance
- Testing should be performed at typical use distance range
Labelling
- User instructions for ultraviolet lamps must clearly identify brand name and model designation of all lamp models for which they are promoted as replacements
Safety
- Replacement lamp must not cause any sunlamp product to fail compliance with the standard
- Replacement lamp must not cause the sunlamp product to become defective as defined by 21 CFR 1003.2
Other considerations
- Promotion of incompatible lamps will be considered as marketing a falsely certified product
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
- Exemptions from Reporting Requirements for Limited Production of Sunlamp Products for Commercial Use
- Quality Control and Quality Assurance for Sunlamp Products and UV Lamps
Related references and norms 📂
- 21 CFR 1040.20: Performance Standards for Sunlamp Products
- 21 CFR 1003.2: Definition of Defect