- Docket Number:
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Guidance Issuing OfficeOffice of Medical Products and Tobacco, Center for Devices and Radiological Health
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.
For purposes of this guidance, the term "laser illuminated projector" (LIP) refers to a type of demonstration laser product2 regulated under 21 CFR 1040.10(b)(13) that is designed to project a display image without the use of raster-scanned collimated laser beams. 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).
Under 21 CFR 1040.10(c), FDA recognizes four major hazard classes (I to IV) of lasers, including three subclasses (IIa, IIIa, and IIIb). Under this classification procedure higher laser classes correspond to more powerful lasers and a higher potential to pose serious danger if used improperly.
As demonstration laser products, LIPs and applications for LIPs cannot exceed Class IIIa emission limits as specified in 21 CFR 1040.11(c) (which is comparable to IEC 60825-1 Ed. 3.03 Class 3R) unless granted a variance by FDA under 21 CFR 1010.4. Some LIPs and applications for LIPs will exceed the Class IIIa limits and therefore require a variance to exceed those emission limits.
This guidance document describes FDA's intent to clarify the application of certain aspects of the performance standard requirements in 21 CFR 1040.11(c) for LIPs. Because the radiant emission levels produced by LIPs can be scientifically characterized by an alternative IEC standard, IEC 62471-5: Ed. 1.0, FDA does not intend to enforce the requirements under 21 CFR 1040.10(c)(1) and 21 CFR 1040.11(c) when LIP manufacturers conform to these standards under the situations outlined in sections III and IV of this guidance. For LIP manufacturers that do not conform with the situations outlined in sections III and IV of this guidance, FDA intends to consider whether those manufacturers' laser products comply with 21 CFR 1040.10(c)(1) and 21 CFR 1040.11(c), among other applicable requirements. Such manufacturers may elect to evaluate their laser products in accordance with FDA's guidance entitled "Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56); Guidance for Industry and FDA Staff" however, sub-clause 4.4 of IEC 60825-1 Ed. 3 would not apply to these products.
1 The requirements for classifying laser products are set forth in 21 CFR part 1040.
2 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."
3 International Electrotechnical Commission (IEC) 60825-1 Ed. 3.0: Safety of laser products - Part 1: Equipment classification, and requirements
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2014-D-2245.