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This document provides guidance on the review criteria for devices intended for the detection of Hepatitis B e antigen and antibody, to assist manufacturers in preparing premarket approval submissions.
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What is deskscan ii - fda?
Deskscan II - FDA is a software system used for scanning and documenting paper-based reports and information related to products regulated by the U.S. Food and Drug Administration (FDA). It is designed to streamline the filing process and ensure compliance with FDA regulations.
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Manufacturers, distributors, and other entities that are regulated by the U.S. FDA and need to submit paper-based reports and information are required to file using Deskscan II - FDA.
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The purpose of Deskscan II - FDA is to facilitate the electronic filing of paper-based reports and information required by the U.S. FDA. It aims to improve efficiency, accuracy, and compliance in the submission process, ultimately improving the management of regulated products.
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The specific information that must be reported on Deskscan II - FDA will vary depending on the type of report or information being submitted. Generally, it may include product details, production processes, quality control measures, adverse events, labeling information, and other relevant information required by the U.S. FDA.
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