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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).

  1. Establish a testing protocol to verify replacement lamp compatibility
  2. Document calculations of maximum exposure times for both original and replacement lamps
  3. Implement verification process to ensure replacement lamps are within ±10% effectiveness of original lamps
  4. Update user instructions to include clear identification of compatible lamp models
  5. Maintain documentation of compatibility testing and calculations
  6. Establish quality control measures to ensure ongoing compliance with safety requirements
  7. Review and update product labeling to reflect correct exposure schedules and timer intervals
  8. 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

  • 21 CFR 1040.20: Performance Standards for Sunlamp Products
  • 21 CFR 1003.2: Definition of Defect

Original guidance

  • Compatibility Criteria for Replacement UV Lamps in Sunlamp Products
  • HTML / PDF
  • Issue date: 1986-09-02
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices
  • ReguVirta summary file ID: ed488d183788bbc175062701a6ecdd38
This post is licensed under CC BY 4.0 by the author.