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Regulatory Requirements and Enforcement Actions for Defective Sunlamp Products Manufactured Before May 7, 1980

This guidance addresses the regulatory requirements and enforcement actions for defective suntanning booths and beds, particularly those manufactured before May 7, 1980. It focuses on products lacking essential safety features like protective eyewear and timers, which are considered serious defects requiring correction under the Federal Food, Drug, and Cosmetic Act (FFDCA).

  1. Assess if suntanning booth/bed has required protective eyewear and timer
  2. If defects are found, identify the manufacturer if possible
  3. If manufacturer is known, pursue enforcement under Subchapter C of FFDCA
  4. If manufacturer is unknown or unresponsive:
    • Notify owner/operator in writing about the defect
    • Request voluntary withdrawal of defective units
    • If non-compliant, initiate detention/seizure under Section 304 of FFDCA
  5. Document all communications and enforcement actions
  6. Consult with HFZ-300 before implementing administrative detention
  7. Ensure corrections are made before allowing equipment back into service

Key Considerations

Safety

  • Protective eyewear must be provided with the suntanning booth/bed
  • Timer must be included in the suntanning booth/bed
  • Absence of either protective eyewear or timer is considered a Class A health hazard

Other considerations

  • 21 CFR 1003: Notification of Defects or Failure to Comply

Original guidance

  • Regulatory Requirements and Enforcement Actions for Defective Sunlamp Products Manufactured Before May 7, 1980
  • HTML
  • Issue date: 2005-02-28
  • Last changed date: 2018-12-01
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Investigation & Enforcement
  • ReguVirta summary file ID: 0c7dde5a9b1d09ba3beff49e473b2ff0
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