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Zdrowie i gospodarka · 02/10/2017

Classification and Requirements for Laser Illuminated Projectors (Laser Notice No. 57); Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57); Draft Guidance for Industry and Food and Drug Administration Staff." When finalized, this guidance describes FDA's policy with respect to certain LIPs that comply with International Electrotechnical Commission (IEC) standards during laser product classification under the Electronic Product Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that apply to electronic products. When finalized, this document will supersede the "Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs); Guidance for Industry and Food and Drug Administration Staff," issued February 18, 2015. This draft guidance is not final nor is it in effect at this time.

Source: Federal Register — Food and Drug AdministrationOpen original release →