Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs): Guidance for Industry and Food and Drug Administration Staff.

摘要

This guidance describes FDA’s policy with respect to certain laser illuminated projectors that comply with International Electrotechnical Commission (IEC) standards during laser product classification1 under the Electronic Product Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that apply to electronic products. The requirements for classifying laser products are set forth in 21 CFR part 1040. The term “demonstration laser product” is defined under 21 CFR 1040.10(b)(13) to mean “any laser product manufactured, designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition.” For purposes of this guidance, the term “laser illuminated projector” (LIP) refers to a type of demonstration laser product defined in 21 CFR 1040.10(b)(13) that is designed to project full-frame digital images. LIPs may be used in locations such as indoor or outdoor cinema theaters, laser shows, presentations at conventions, as image/data projectors in an office setting, or in a home. Lasers are being used in LIPs as an alternative to conventional lamps in projectors. Although these LIPs emit laser light from extended sources and their uncollimated beams do not present the same hazards as other lasers, they are laser products that present risks and must undergo classification in accordance with 21 CFR 1040.10(c).