The U.S. FDA’s annual reporting requirements

• As a laser light show variance holder, you are required to report information about the shows you produce to the FDA on an annual basis. By properly logging show information as described previously, you will have accumulated most of the information you will need for your annual report.
• In most cases, annual reports are due before September 1st of each year for shows produced that calendar year. See your variance for the exact due dates for annual reports
• Find the report and detailed instructions of how to properly fill out an annual report within the “FORM FDA 3636”. (In support Docs )
• Also see the FDA’s Laser Notice #55 (In support Docs)

Download the Annual reporting guide and form.