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).
Recommended Actions
- Assess if suntanning booth/bed has required protective eyewear and timer
- If defects are found, identify the manufacturer if possible
- If manufacturer is known, pursue enforcement under Subchapter C of FFDCA
- 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
- Document all communications and enforcement actions
- Consult with HFZ-300 before implementing administrative detention
- 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
- Products are subject to defect regulations under 21 CFR 1003
- Products are considered medical devices subject to FFDCA provisions
- Enforcement actions can be taken under Subchapter C of FFDCA or Section 304 of FFDCA
- Owner/operator must be notified in writing to discontinue use of defective equipment
- Administrative detention should be discussed with HFZ-300 before implementation
Relevant Guidances
- Applicability of Sunlamp Performance Standards to UVA Tanning Products (Revoked)
- Recordkeeping Requirements and Exemptions for Portable Home Sunlamp Products and UV Lamps
- Exemptions from Reporting Requirements for Limited Production of Sunlamp Products for Commercial Use
- 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 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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