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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.

  1. Determine the number of sunlamp products intended for manufacture
  2. If manufacturing less than 10 units:
    • Submit notification to Director, Division of Compliance
    • Include manufacturing location details
  3. If manufacturing more than 10 units:
    • Prepare written exemption application
    • Include production quantity and timeline
  4. Maintain compliance with performance standard requirements regardless of exemption status
  5. Prepare for potential FDA product inspections
  6. 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

  • 21 CFR 1040.20: Performance Standard for Sunlamp Products
  • 21 CFR 1002: Records and Reports

Original guidance

  • Exemptions from Reporting Requirements for Limited Production of Sunlamp Products for Commercial Use
  • HTML / PDF
  • Issue date: 1981-09-16
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products
  • ReguVirta summary file ID: 193097923920bfdba8e5f37eade24a69
This post is licensed under CC BY 4.0 by the author.