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FDA eSubmitter (Radiation Safety Report Video Tutorial and Updated User Guide)

Fri, 03/11/2011 - 9:30am
U.S. Food & Drug Administration

The Food and Drug Administration's eSubmitter tool is part of an electronic submissions program that is available for voluntary use by sponsors, manufacturers, and importers to create a variety of submission types within the blood, device, radiological health, tobacco and animal drug regulated industries.

Description: The FDA eSubmitter tool is a stand-alone application that allows the input of data and compilation of an FDA-compatible output submission file. The application and any output files reside locally on your computer allowing users to work on a submission offline, save, and continue later. The eSubmitter tool does not transmit any compiled data across the web to FDA. It is the responsibility of each user for the security of the application and data contained within it. The FDA does not have the ability to access, review, or supplement the information on your local computer through this application.

The FDA eSubmitter is a free software that currently supports the creation of the following submission types. Please note that the method for sending completed submissions to FDA differs based on the Center and submission type being transmitted. The Transmission method refers to the FDA's Electronic Submissions Gateway, or ESG.

CenterOfficeSubmission TypeTransmission Method
CBEROffice of Blood Research and Review (OBRR)Source Plasma BLA/BLS and Annual ReportCD
CDRHOffice of Communication, Education, and Radiation Programs (OCER)Assembler Reports (form 2579)Gateway
CDRHOffice of Communication, Education, and Radiation Programs (OCER)Radiological Health Reports and CorrespondenceGateway or

CD

CDRHOffice of In-Vitro Diagnostic Devices (OIVD)Turbo 510(k)CD
CDRHOffice of Surveillance and Biometrics (OSB)Electronic Medical Device Reporting (eMDR)(form 3500A)Gateway

 

CTPOffice of Compliance and Enforcement (OCE)Establishment Registration and Product ListingGateway or

CD

CTPOffice of Science (OS)Tobacco Product Ingredient Listing Submissions and Health DocumentsGateway or

CD

CVMOffice of New Animal Drug Evaluation (ONADE)

 

All submission types to include (J)INAD, (A)NADA, VMF, and GC files and applicationsGateway Only

FDA's ESG is separate from the eSubmitter tool. The ESG is an agency-wide entry point for various electronic submissions. The ESG authenticates and validates electronic submissions and routes it to the appropriate Center. Please visit http://www.fda.gov/esg/ to register as a trading partner for an initial ESG test account. Upon successful transmission of the test submission, your account will be promoted to a production account and you can start submitting required documents to FDA electronically.

See the Quick Guide for packaging guidelines for participating eSubmitter Programs.

The FDA eSubmitter tool is government-issued software governed by the Government Paperwork Elimination Act of 1998. As a user of this software you are not required to perform your own validation. However, if you decide to use the software for purposes other than the intended uses identified above, you may be required to comply with additional requirements applicable to that intended use. For example, if you store created electronic records locally, for purposes other than an intended use identified above, you may be responsible for additional regulatory requirements including but not limited to validation, change control, and electronic signatures associated with your changes to the software.

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