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FDA's MITACS Account Management Import Trade Auxiliary Communications System January 2017 Food and Drug Administration Division of Systems Solutions Import Systems BranchTopics Background and Overview
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How to fill out fda itacs

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How to Fill Out FDA ITACS:

01
Start by visiting the FDA's official website and locating the ITACS (Import Trade Auxiliary Communications System) portal.
02
Create an account on the ITACS portal by providing the required information, such as your email address and contact details. Make sure to choose a strong password to protect your account.
03
Familiarize yourself with the different sections and features of the ITACS portal. This includes understanding the various tabs, menus, and options available for importing goods.
04
Determine the type of FDA-regulated product you wish to import and identify the specific requirements and regulations associated with it. This information can typically be found on the FDA's website or by consulting with an FDA representative.
05
Access the relevant forms and documentation necessary for importing your specific product. These forms may include the FDA Form 2877 (Declaration for Imported Electronic Products Subject to Radiation Control Standards) or the FDA Form 2877a (Declaration for Imported Electronic Products Subject to Radiation Control Standards - Additional Devices).
06
Fill out the required fields in the forms accurately and completely. Provide all necessary information, such as product description, manufacturer details, intended use, labeling, packaging, and any other relevant data.
07
Review your completed forms and double-check for any errors or missing information. It's important to ensure that all information provided is current, accurate, and compliant with FDA regulations.
08
Submit the forms electronically through the ITACS portal. Follow the designated steps and prompts to attach the necessary supporting documentation, such as invoices, certificates, or lab test reports.
09
Pay any applicable fees associated with the FDA import process. The ITACS portal will provide options for online payment, and it's essential to complete this step to avoid delays or complications.
10
Track the progress of your submitted forms and import requests through the ITACS portal. You can monitor updates, notifications, and any additional requirements communicated by the FDA.

Who Needs FDA ITACS:

01
Importers of FDA-regulated products: Any individual or business entity that wishes to import FDA-regulated products into the United States needs to utilize the ITACS system. This includes both domestic companies importing foreign products and foreign companies exporting goods to the U.S.
02
Manufacturers and distributors: Companies involved in the manufacturing or distribution of FDA-regulated products may also need to access the ITACS system. This is particularly important for ensuring compliance with FDA regulations and facilitating the importation process.
03
FDA agents and consultants: FDA agents and consultants who assist importers in navigating the regulatory requirements may also require access to the ITACS system. It enables them to manage import requests, submit documentation, and communicate with the FDA on behalf of their clients.
Overall, anyone involved in the importation of FDA-regulated products, including importers, manufacturers, distributors, and consultants, would need to utilize the FDA ITACS system. It serves as a crucial platform for complying with FDA regulations and facilitating the import process smoothly.
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FDA ITACS stands for FDA Import Trade Auxiliary Communications System. It is an electronic system used by the FDA to communicate important information related to imported products.
Importers and brokers who are involved in the importation of FDA-regulated products are required to file FDA ITACS.
FDA ITACS can be filled out online through the FDA's Import Trade Auxiliary Communications System website.
The purpose of FDA ITACS is to facilitate communication between the FDA and importers/brokers to ensure the safe importation of FDA-regulated products.
Information such as product details, manufacturer information, quantity, intended use, and country of origin must be reported on FDA ITACS.
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