If you operate laser light shows in the United States, maintaining your FDA variance is an important part of operating legally and safely. The filing process should not take time away from designing your laser shows and your business.
That is why we are proud to introduce a new online Annual Report Filing System for our clients in the United States. It is designed to make the process easier and give you one less thing to worry about when dealing with the FDA.
To maintain your existing variance, you must submit an annual report covering your laser light show activity from July 1 of the previous year through June 30 of the current year. Annual reports may be submitted beginning July 1 and must be filed before September 1.
Previously, this meant completing the required FDA form and physically mailing it yourself. Now, we can take care of the filing for you.
Simply complete our online form with your information and the number of laser shows you produced during the reporting period. Our system prepares the required annual report paperwork, and our compliance team files it on your behalf.
File Your Annual Report Online
Don't have an FDA variance yet?
This annual report filing service is only for clients in the United States who already have an FDA variance.
If you are in the United States and have not yet filed your initial variance, you can begin the application process through our online form. After you complete the application, our compliance team will file your variance with the CDRH and FDA using the information you provide.
Got questions?
Our compliance team is here to help. Reach out to compliance@pangolin.com with any questions about filing your annual report or applying for an FDA variance.
At Pangolin, our goal is to make laser compliance clearer and easier, so you can spend less time on paperwork and more time creating incredible laser shows.
Disclaimer
Pangolin provides this Annual Report filing service at no charge as a courtesy to Pangolin customers. The service includes preparing and submitting FDA Form 3636 using the information you provide.
You are responsible for ensuring that all information is complete and accurate and that it is provided with enough time to meet the applicable filing deadline. Pangolin cannot guarantee FDA acceptance, approval, processing times, or continued availability of this service.
Pangolin is not responsible for delays, rejected filings, expired variances, or other consequences resulting from incomplete, inaccurate, or late information, technical interruptions, FDA actions, or circumstances outside our reasonable control.
This service is limited to preparing and submitting FDA Form 3636. It does not include legal advice, regulatory representation, expedited FDA processing, or assistance resolving unrelated compliance issues.
