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Draft Not for Implementation Attachment IV Sample Formats User Fee Form FDA 3397 for Ammonia N 13 Injection Fleudioxyglucose F 18 Injection FDG F 18 and Sodium Fluoride F 18 Injection J PET GUIDANCE feesampl.doc.dot 2/25/00 Form Approved OMB No. 0910-0297 Expiration Date 04-30-01 DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION USER FEE COVER SHEET See Instructions on Reverse Side Before Completing This Form 1. APPLICANT S NAME AND ADDRESS 3....
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Individuals or organizations involved in activities regulated by the FDA may require FDA Form 3397.
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This form is typically used for various purposes such as product registrations, facility registrations, or to provide notification to the FDA.
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Specific industries such as food and beverages, drugs and medical devices, cosmetics, tobacco products, and biologics may require the use of this form for regulatory compliance.
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What is fda form 3397?
FDA Form 3397 is a document used for reporting certain information to the U.S. Food and Drug Administration (FDA).
Who is required to file fda form 3397?
The specific parties required to file FDA Form 3397 may vary depending on the purpose of the form. It could be manufacturers, distributors, or other entities involved in the production or distribution of regulated products.
How to fill out fda form 3397?
To fill out FDA Form 3397, you need to gather the required information and complete the form fields as specified by the FDA. The form typically includes sections for providing identifying information, details of the product, and any relevant safety or adverse event data.
What is the purpose of fda form 3397?
The purpose of FDA Form 3397 is to collect information about regulated products, including any adverse events or safety concerns. This data helps the FDA identify potential issues, monitor product safety, and take appropriate regulatory actions.
What information must be reported on fda form 3397?
The specific information to be reported on FDA Form 3397 may vary depending on the purpose of the form. However, it commonly includes details such as product identification, adverse event descriptions, patient information, and contact information of the reporter.
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