The FDA's Center for Devices and Radiological Health (CDRH) has released a new tool to collect submission data as part of a software version upgrade for its electronic submissions program, CeSub (CDRH electronic Submissions).
The software application is intended to automate the current paper submission process for the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), Rad Health and Medical Device Adverse Event (MDR) programs, according to the CDRH.
CeSub eSubmitter is a free, 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.
CDRH said that the CeSub eSubmitter allows sponsors to:
- electronically complete and submit premarket notification applications [ 510(k)] to the 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; and
- electronically complete and submit the Medwatch 3500A form for medical device adverse event reports.
The new tool includes features such as the semi-automatic acknowledgement message to the submitter and manufacturer, the address book and contacts book, PDF files as attachments to the submission or the report, the "missing Data Report," and the ability to save submissions or reports to a hard-drive.
There are new features including multiple PDF attachments, improved "Create a Submission" procedure and more guidance information. Also, the software is capable of providing automatic updates from the FDA website each time the user opens the application when connected to the internet, the agency said.