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This form is used to notify the FDA about a new use of a food contact substance. It includes sections that require general information, chemistry information, intended use, stability data, and estimated daily intake, among other requirements. The notifier must provide comprehensive details regarding safety, manufacturing information, and environmental considerations.
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How to fill out fda 3480
How to fill out fda 3480
01
Obtain FDA Form 3480 from the FDA website or designated source.
02
Fill in your name, address, and contact information in the applicant section.
03
Provide information about the product, including its name, description, and intended use.
04
Indicate the purpose of your application in the relevant checkbox.
05
List any prior submissions related to the product, if applicable.
06
Sign and date the form to certify the information provided is accurate.
07
Submit the completed form to the FDA as per their submission guidelines.
Who needs fda 3480?
01
Manufacturers and importers of medical devices that require premarket notification or are changing the labeling of an existing device.
02
Entity seeking approval or clearance for a new medical device or changes to an existing device.
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What is fda 3480?
FDA 3480 is a report form that must be submitted to the U.S. Food and Drug Administration (FDA) for certain medical devices and other products to ensure regulatory compliance.
Who is required to file fda 3480?
Manufacturers, importers, and distributors of medical devices, as well as other entities involved in the product's lifecycle, are required to file FDA 3480.
How to fill out fda 3480?
Filling out FDA 3480 requires providing specific information about the device, including its classification, intended use, and any adverse events reported. Detailed instructions can be found on the FDA's official website.
What is the purpose of fda 3480?
The purpose of FDA 3480 is to collect necessary information about medical devices to monitor their safety and effectiveness and to enforce compliance with regulatory standards.
What information must be reported on fda 3480?
Information that must be reported on FDA 3480 includes device details, manufacturing information, adverse events, and any corrections or removals related to the product.
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