Applicability of Sunlamp Performance Standards to UVA Tanning Products (Revoked)
This guidance addresses the applicability of sunlamp performance standards to UVA tanning products. However, it's important to note that this guidance has been revoked effective June 20, 2002, per Federal Register dated May 21, 2002.
Recommended Actions
- Do not rely on this guidance as it has been revoked
- Consult current FDA regulations and guidance documents regarding sunlamp and UV tanning devices
- Review the current performance standards for light-emitting products under 21 CFR 1040
- Seek updated regulatory requirements for UVA tanning products
- Consider consulting with FDA directly for current requirements related to sunlamp and tanning devices
Key Considerations
Other considerations
- This guidance has been revoked and is no longer in effect
- The document was originally related to radiation-emitting products and medical devices
- The guidance was specifically focused on sunlamp performance standards
Relevant Guidances
- 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
- Quality Control and Quality Assurance for Sunlamp Products and UV Lamps
- Exemptions from Reporting Requirements for Limited Production of Sunlamp Products for Commercial Use
Related references and norms
- 21 CFR 1040: Performance Standards for Light-Emitting Products
Original guidance
- Applicability of Sunlamp Performance Standards to UVA Tanning Products (Revoked)
- HTML
- Issue date: 1995-02-28
- Last changed date: 2018-12-01
- Status: FINAL
- Official FDA topics: Medical Devices, Radiation-Emitting Products, Investigation & Enforcement
- ReguVirta summary file ID: 97825606576e505cb3657d8324853204
This post is licensed under CC BY 4.0 by the author.