If you have an FDA laser light show variance, submitting your annual report to the FDA is what allows your variance to automatically renew. The annual deadline for filing your annual report with the FDA is September 1. There is no charge to file your annual report, and with the help of the guide we've created (included below), completing and submitting your annual report takes less than 30 minutes.
If you've never filed an annual report or if you won't be able to submit your annual report by September 1, that's not ideal, but please file a report as soon as you are able.
To help guide you in filling and submitting your annual report, we have written a short PDF guide with step-by-step instructions. "Your Guide to the FDA Annual Report" covers all of the FAQs, and includes all the information you need to quickly and easily file your report using the fillable form we've created for X-Laser users.
The "Fillable PDF Annual Report Form" that we created with some of the data already input is applicable for the vast majority of X-Laser users. If the answers in that pre-filled form are not applicable to how you use your laser system, or if you use lasers made by a different company, your other option is to use and file FDA Form 3636:
Of course, if you have any questions about the variance process, you can always reach out to variances@x-laser.com. If you've read through the material here and still have questions about the annual report or FDA laser light show variance in general, let us know so we can improve the info!
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