This is a legal form that was released by the U.S. Department of Health and Human Services - U.S. Food and Drug Administration on December 1, 2020 and used country-wide. As of today, no separate filing guidelines for the form are provided by the issuing department.
Q: What is Form FDA3147?
A: Form FDA3147 is an application for a variance from 21 CFR 1040.11(c) for a laser light show, display, or device.
Q: What is 21 CFR 1040.11(c)?
A: 21 CFR 1040.11(c) is a regulation that pertains to the performance standards for laser products.
Q: What is a variance?
A: A variance is an exception or deviation from a standard requirement.
Q: Why would someone need a variance for a laser light show?
A: Someone would need a variance for a laser light show if they want to use laser products that do not meet the performance standards outlined in 21 CFR 1040.11(c).
Q: What information is required on Form FDA3147?
A: Form FDA3147 requires information such as the applicant's name, contact information, description of the laser light show, and justification for the variance request.
Q: How long does it take to process a variance request?
A: The processing time for a variance request can vary, but it generally takes several weeks to months to receive a response from the FDA.
Form Details:
Download a fillable version of Form FDA3147 by clicking the link below or browse more documents and templates provided by the U.S. Department of Health and Human Services - U.S. Food and Drug Administration.