The Center for Devices and Radiological Health (CDRH) has an electronic submissions program, referred to as CeSub (CDRH electronic Submissions). CeSub evolved as a result of two very successful pilot programs named “eLaser,” and “Turbo 510(k)”. 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 device and Radiological Health industries.This software application is intended to automate the current paper submission process to the OIVD, Rad Health and Medical Device Adverse Event (MDR) programs.
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)
Electronically complete and submit information for a variety of radiation safety Product Reports and Annual Reports for radiation emitting products to the Radiological Health Program.
Electronically complete and submit the Medwatch 3500A form for medical device adverse event reports.
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