Food And Drug Administration

Ultraviolet lamps and accessory equipment have been proposed for classification into Class II. Instructions for preparation of a pre-market notification to the Food and Drug Administration and registering a firm as a medical device manufacturer may be found in 21 CFR 801 (Labeling), 21 CFR 803 (Medical Device Reporting), 21 CFR 807 (Establishment Registration and Device Listing for Manufacturers of Devices) and 21 CFR 808 (Exemptions from Federal Preemption of State and Local Medical Device Requirements).

A manufacturer of a sunlamp or sunlamp product is any person engaged in the business of manufacturing, assembling or importing a sunlamp or sunlamp product designated to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the living body, by ultraviolet radiation with wavelengths in air between 200 nm and 400 nm, to induce skin tanning.

Manufacturers are required, under Part 1002 of the regulations for the enforcement of the Radiation Control for Health and Safety Act of 1968, to submit an initial report and model change reports for new or modified product models. These reports must be submitted prior to the introduction of a product into commerce and must be prepared in accordance with the "Reporting Guide for Initial Reports and Model Change Reports on Sunlamps and Sunlamp Products."

The Sunlamp Product Performance Standard, 21 CFR 1040.20, located in the regulations for the enforcement of the Act, initially became effective on May 7, 1980. All sunlamps and sunlamp products manufactured or offered for entry into the United States on or after May 7, 1980, are subject to the code. For products such as suntanning booths, couches or beds, the Center also issued equipment recommendations. In addition to the standard, these recommendations also had to be met prior to introducing a product into commerce.

The standard was amended to include many of the equipment recommendations and better address certain safety issues in September 1985. The amended version took effect on Sept. 8, 1986; all sunlamps and sunlamp products made or submitted for entry into the United States on or after this effective date must comply with the amended standard.

Failure to certify products as required in the code or to provide the required reports or to maintain the required records are violations of Section 538, Chapter V, FDDCA (Section 360B, RCHSA) and may result in the imposition of the penalties, specified in Section 539 (Section 360C, RCHSA).

The reporting and recordkeeping requirements are set forth in Part 1002. In brief, manufacturers, importers and assemblers are required to submit: