Federal Register :: Public Inspection: Guidance: Classification and Requirements for Laser Illuminated Projectors

Federal Register :: Public Inspection: Guidance: Classification and Requirements for Laser Illuminated Projectors



Dear Colleague,

Today, the U.S. Food and Drug Administration announced updated draft guidance intended to clarify the FDA performance standard requirements and the International Electrotechnical Commission (IEC) lamp standard for LIPs.   

The draft guidance, titled “Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57); Draft Guidance for Industry and Food and Drug Administration Staff,” outlines how to determine if laser projectors are LIPs, how to classify LIPs into risk groups, and how to meet appropriate safety requirements. This draft guidance will be open for public comments and suggestions in the Federal Register for 60 days under Docket Number: FDA-2014-D-2245. 

When final, this guidance will replace the Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs) dated February 18, 2015.

Thank you.
Center for Devices and Radiological Health
Food and Drug Administration