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This document is a notification form for new uses of food contact substances, required by the U.S. Food and Drug Administration. It outlines the process for submitting a notification, including general

How to fill out fda form 3480

How to fill out FDA FORM 3480

1. Collect all necessary information regarding the device, including its name, identification number, and the manufacturer's details.
2. Fill out the applicant's information section, including the name, address, telephone number, and email of the individual or entity submitting the form.
3. Provide a detailed description of the device, including its intended use and how it works.
4. Specify the classification of the device under FDA regulations.
5. Enter the relevant FDA product code in the designated field.
6. If applicable, provide information about any previous submissions or communications with the FDA regarding the device.
7. Sign and date the form at the bottom to certify that the information provided is accurate and complete.
8. Submit the completed form to the FDA through the appropriate channel, either electronically or by mail.

Who needs FDA FORM 3480?

1. Manufacturers or developers of medical devices seeking to obtain premarket clearance or approval from the FDA.
2. Companies that need to report any adverse events related to their devices.
3. Individuals or organizations involved in the regulation of medical devices in the U.S.

People Also Ask about

What is form FDA 3794?

Abstract: Form FDA 3794, the Generic Drug User Fee Amendments Cover Sheet, requests the minimum necessary information from applicants to determine the total amount of generic drug user fees required, and to account for and track user fees.

What is food contact testing?

FOOD CONTACT MATERIALS REGULATORY STANDARDS Materials that come into contact with food, like manufacturers' packaging, crockery and cutlery, glassware, ceramics and storage containers, need to be tested before they come in contact with food.

What is the FDA food contact migration testing?

This process includes analyzing testing data that demonstrates the amount of migration of a food contact substance to food because of its intended use, and toxicological data to ensure that the consumer exposure resulting from this migration is safe.

What are the FDA requirements for food contact?

For new food contact substances, manufacturers must register the product with the FDA. This typically requires a Food Contact Notification (FCN), but for higher or lower exposure materials, a Food Additive Petition (FAP) or Threshold of Regulation Submission (ToR) may be necessary.

What is a migration test?

Food contact migration testing is key to verifying safety and establishing food contact compliance. Migration limits for the transfer of chemical substances from FCM into food have been established for food packaging materials based on the toxicological risk assessment and potential risk to human health.

What is the FDA food contact Notification Program?

FCSs are evaluated primarily through the food contact notification (FCN) program. Federal law requires companies who wish to use a food contact substance to submit Food Contact Substance Notifications (FCNs) to FDA prior to marketing the product. The FDA has a mandated 120-day time-period to review that submission.

What is the FDA no migration principle?

The demonstration that a substance could not (in the case of calculations or diffusion modeling) or does not (in the case of actual migration studies) migrate to food at or above the chosen level of analytical sensitivity provides the legal basis for determining that a "No Migration" position is appropriate, and

What is the FDA form 1571 used for?

What is the FDA 1571 form? Form FDA 1571 is used for two purposes: 1) to obtain agreement from the sponsor (or sponsor-investigator) to conduct research according to all appropriate FDA regulations; and 2) to serve as a cover sheet for all submissions to the FDA on behalf of a particular IND.

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What is FDA FORM 3480?

FDA FORM 3480 is an official document used to report adverse events or product defects related to medical devices, ensuring that the FDA is informed about potential safety issues.

Who is required to file FDA FORM 3480?

FDA FORM 3480 must be filed by manufacturers, importers, and device user facilities when they become aware of adverse events involving their medical devices.

How to fill out FDA FORM 3480?

To fill out FDA FORM 3480, users must provide detailed information including the device's identification, description of the adverse event, patient information, and any actions taken regarding the incident.

What is the purpose of FDA FORM 3480?

The purpose of FDA FORM 3480 is to facilitate the reporting and tracking of adverse events associated with medical devices, helping the FDA monitor device safety and effectiveness.

What information must be reported on FDA FORM 3480?

FDA FORM 3480 requires reporting of device details, the nature of the adverse event, patient demographics, outcome of the event, and any subsequent actions taken by the reporting entity.