Description
Sunlamp products, suntanning booths and beds manufactured prior to May 7, 1980, are not subject to the sunlamp performance standard; however, these electronic products are subject to the defect regulations under 21 CFR 1003 and the Chapter V, Subchapter C of the Federal Food, Drug, and Cosmetic Act (FFDCA), formerly known as the Radiation Control for Health and Safety Act of 1968 (RCHSA). Suntanning products, booths, and beds are also medical devices subject to the other provisions of the FFDCA.
Scope & Applicability
Product Classes
3Medical devices subject to FFDCA provisions
Medical devices subject to FFDCA provisions
Products subject to the performance standard
Stakeholders
2Not required to correct but requested to withdraw hazardous units
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Identified Hazards
Hazards
1Defined in CP 7386.002 for suntanning devices
See Also (7)
- CPG Sec. 398.375 Obligations of Factory-based Manufacturers and Assemblers of Diagnostic X-ray Equipment Under the Performance Standard for Diagnostic X-ray Equipment (Status: Final)
- Compliance Guide for Laser Products (FDA 86-8260) (Status: Final)
- Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54): Guidance for Industry and FDA Staff (Status: Final)
- Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53) (Status: Final)
- Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55) (Status: Final)
- Compliance Policy Guide Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect - 21 CFR 1003.11 (Status: Final)
- Product Recalls, Including Removals and Corrections: Guidance for Industry (Status: Final)