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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2015]
[CITE: 21CFR878.4635]
See Related Information on Sunlamp products and ultraviolet lamps intended for use in sunlamp products. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES

Subpart E--Surgical Devices

Sec. 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.

(a) Identification. A sunlamp product is any device designed to incorporate one or more ultraviolet (UV) lamps intended for irradiation of any part of the living human body, by UV radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning. This definition includes tanning beds and tanning booths. A UV lamp intended for use in sunlamp products is any lamp that produces UV radiation in the wavelength interval of 200 to 400 nanometers in air.

(b) Classification. Class II (special controls). The special controls for sunlamp products and UV lamps intended for use in sunlamp products are:

(1) Conduct performance testing that demonstrates the following:

(i) Device meets appropriate output performance specifications such as wavelengths, energy density, and lamp life; and

(ii) Device's safety features, such as timers to limit UV exposure and alarms, function properly.

(2) Demonstrate that device is mechanically safe to prevent user injury.

(3) Demonstrate software verification, validation, and hazard analysis.

(4) Demonstrate that device is biocompatible.

(5) Demonstrate that device is electrically safe and electromagnetically compatible in its intended use environment.

(6) Labeling --(i) Sunlamp products. (A) The warning statement below must appear on all sunlamp products and must be placed in a black box. This statement must be permanently affixed or inscribed on the product when fully assembled for use so as to be legible and readily accessible to view by the person who will be exposed to UV radiation immediately before the use of the product. It shall be of sufficient durability to remain legible throughout the expected lifetime of the product. It shall appear on a part or panel displayed prominently under normal conditions of use so that it is readily accessible to view whether the tanning bed canopy (or tanning booth door) is open or closed when the person who will be exposed approaches the equipment and the text shall be at least 10 millimeters (height). Labeling on the device must include the following statement:

Attention: This sunlamp product should not be used on persons under the age of 18 years.

(B) Manufacturers shall provide validated instructions on cleaning and disinfection of sunlamp products between uses in the user instructions.

(ii) Sunlamp products and UV lamps intended for use in sunlamp products. Manufacturers of sunlamp products and UV lamps intended for use in sunlamp products shall provide or cause to be provided in the user instructions, as well as all consumer-directed catalogs, specification sheets, descriptive brochures, and Web pages in which sunlamp products or UV lamps intended for use in sunlamp products are offered for sale, the following contraindication and warning statements:

(A) "Contraindication: This product is contraindicated for use on persons under the age of 18 years."

(B) "Contraindication: This product must not be used if skin lesions or open wounds are present."

(C) "Warning: This product should not be used on individuals who have had skin cancer or have a family history of skin cancer."

(D) "Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer."

(c) Performance standard. Sunlamp products and UV lamps intended for use in sunlamp products are subject to the electronic product performance standard at 1040.20 of this chapter.

[79 FR 31213, June 2, 2014]

The information on this page is current as of April 1 2015.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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