Information: Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs)

Dear Colleague,

Today, the U.S. Food and Drug Administration announce the availability of a guidance entitled “Immediately in Effect Guidance: Classification and Requirements for Laser Illuminated Projectors (LIPs); Guidance for Industry and Food and Drug Administration Staff.”   This guidance document describes FDA’s intent to clarify the application of certain aspects of the FDA performance standard requirements and the IEC lamp standard for LIPs.

The FDA’s new guidance for industry outlines procedures for determining if laser projectors are LIPs, categorizing LIPs as either high-risk or low-risk, and how to meet appropriate safety requirements for each.

You can find further information here: Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs)

Thank you.

Center for Devices and Radiological Health

Food and Drug Administration