Policy on Warning Label Required on Sunlamp Products June 1985

GUIDANCE DOCUMENT

• Docket Number: FDA-2020-D-0957
• Issued by: Center for Devices and Radiological Health

The Center for Devices and Radiological Health has found numerous imported and domestic sunlamp products labeled in such a way as to render the label illegible and/or inaccessible to view by the consumer under normal conditions of purchase and use.

Sunlamp products are electronic products as defined by Section 355(2) [42 U.S,C 263c(2)1 of the Radiation Control for Health and Safety Act of 1968 (RCHSA) and medical devices as defined by Section 201(h)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C) [21 U.S.C.321(h)(3)1. The performance standard for sunlamp products (21 CFR 1040.20) promulgated under authority of Section 358 of the RCHSA, requires that labels containing specific information be permanently affixed or inscribed on an exterior surface of the product so as to be legible and readily accessible to view when the product is fully assembled for use. The general labeling provisions for medical devices under 21 CFR 801.5 require adequate directions for use be provided to the user and 21 CFR 801.15 defines the prominence of the required label statements for devices.

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