Updated: Sep 25, 2022
This document was issued on September 22, 2022. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.
This guidance includes specifications for electronic submission of premarket notifications (510(k)), a schedule for setting them up, and criteria for waiving or exempting from statutory requirements.
Also, this guide will provide a process for the development of templates to facilitate the preparation, submission, and review of regulatory submissions for medical devices solely in electronic format. This document provides guidance on the FDA’s interpretation of the statutory requirement for electronic submissions solely in electronic format.
Therefore, to the extent that this guidance describes recommendations that are not “standards,” “timetable,” or “criteria for waivers” and “exemptions” under section 745A(b)(3) of the FD&C Act.
The electronic submission template includes the information and guided prompts FDA believes will best facilitate the collection and assembly of the necessary elements of ‘complete’ submission, as required by regulation or essential to the FDA’s substantive review of the 510(k) submission.
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