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Medical Devices / Regulatory Affairs / Postmarket Safety

FDA to Release a New Version of Submission Software

Nov. 7, 2017
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FDA software used by medical device manufacturers to submit reports of adverse events, corrections and removals is being updated without any downtime for the first time.

The agency said it will release version 3.0 of the eSubmitter 2.x.x during December, which will require a new installation. eSubmitter 2.x.x can continue being used until May 7, 2018, when it will be disabled.

Pilgrim Quality Solutions, a software company that contributed to the creation of eSubmitter, says the agency wants to use data analytics as a guide to improve efficiency and make better use of its resources.

It makes sense for the FDA to prepare for future expansions of eSubmitter’s capacity to prepare and transmit files to the FDA gateway and this is what version 3.0.0 will allow the agency to do, Bernard Jee, Pilgrim’s product manager for the company’s eMDR area, told FDAnews. The goal is to get a broader view of the available information.

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