Laser Regulation Process and Detail
FDA will be monitoring regulatory compliance of Laser Light Show Manufacturers and other operators of Laser Light Shows in the venue, Wednesday, January 24 – Sunday, January 28, 2018. This will include verifying that all operators have an approved Variance, and are operating in accordance with any conditions imposed by the Variance. In addition, FDA will be networking and available to answer any questions regarding distribution of laser products in the US or other matters.
Electronics Engineer / Electro-Optics Specialist
781-756-9730 | firstname.lastname@example.org
Important Information and Links:
The operation and demonstration of high power laser light shows is a public safety issue, particularly when operated by those who are untrained or unfamiliar with the FDA requirements to ensure product safety. By FDA regulation, laser projectors must incorporate specific features if they exceed a power level of 5 mW (milli-Watts). In addition, they are prohibited to be operated or demonstrated in the US without an approved Variance that dictates specific conditions and limitations of use that must be followed as a condition of the approval. The approved Variance requirement applies to “Laser Show Companies” (operators) as well as the Manufacturers / Dealers / Distributors of these products who offer their products for US sale as well as demonstrating them in public venues.
Laser Notice 51 (Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors) is a brief 5 page guidance document that describes the procedure and documentation needed to obtain approval for operating a high power laser light show. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094448.pdf
Laser Notice 55 (Procedures for Renewal and Amendment of Certain Laser Light Show Variances) describes the procedures under which the Laser Light Show Variance can be automatically renewed annually. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094356.pdf
Link to FDA’s Laser Light Show splash page (scrolling down to “Industry Guidance”) summarizes the requirements in yet another way. Please note the instruction “Your firm can begin to produce laser light shows only after receipt of a variance approval letter from FDA indicating the conditions under which you may produce the laser light show or distribute laser light show projectors” http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/ucm118907.htm
Here is a more detailed Compliance Guide for Laser Products (see Page 20, “Clarification of Certain Laser Light Show Requirements”) http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095304.pdf
Two basic forms are required to be submitted to obtain a variance:
Application for Variance http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM080788.pdf
Laser Light Show Report http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM081634.pdf
In addition, a product report is required from Laser Manufacturers to demonstrate their products comply with the Federal Laser erformance Standard (except as permitted by the variance). http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM081592.pdf