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Turbo 510(k) Electronic Submissions

Contents

General Information

The Center for Devices and Radiological Health (CDRH) has an electronic submissions program, referred to as CeSub (CDRH electronic Submissions).

After a very successful pilot program named “Turbo 510(k)” in which OIVD distributed software applications for the 510(k) submissions for In Vitro Diagnostic Devices, the CeSub program prepared the next version of the software, a new tool to collect submission data. This new software tool is called CeSub eSubmitter. CeSub eSubmitter is an improved and expanded package for a variety of submission types and is now available for voluntary use by the sponsors and manufacturers in the in vitro diagnostic devices industry. CeSub eSubmitter is free software that allows sponsors to electronically complete and submit premarket notification applications [ 510(k)] to the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

This software application is intended to automate the current paper submission process to the OIVD .This software contains a number of data capturing tools and helpful dialog boxes to reduce redundant responses for you, and to allow us to capture data in a more useful, structured format. These benefits will improve our review process and reduce lengthy review times at OIVD. If you are interested in requesting the new CeSub eSubmitter software, please feel free to download it below.

The CeSub software may be used to submit 510(k) applications for In Vitro Diagnostic Devices reviewed at OIVD. Currently the software will support single and “bundled” applications for all traditional, abbreviated, and special 510(k)s including:

  • Antimicrobial Susceptibility Testing (AST) Devices
  • All Other In Vitro Device Types
  • CLIA Waver and Categorization Applications

The Software may also be used to submit 510(k) Supplements. Additional updates are currently under development and will be available on a continuous basis to the users every time the software is launched while connected to the internet.

Download Software

To download the new CeSub software and user manual please use the following links:

Download CeSub Software

Download User Manual

New! Frequently Asked Questions on CeSub and OIVD

Updated February 6, 2008

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