USA – Electronic Device Submissions: FDA Drafts Guidance

Thanks to the FDA Reauthorization Act of 2017 (FDARA), the US Food and Drug Administration (FDA) on Wednesday published a new draft guidance with “both binding and nonbinding provisions” related to electronic submissions for medical devices.

At the outset of the seven-page draft, FDA warns that it has concluded “that it is not feasible to describe and implement the electronic format(s) that would apply” to all the device submissions in one guidance document, so this guidance describes how FDA interprets and plans to implement the requirements of section 745A(b)(3), which FDARA created, while individual guidance documents will be developed to specify the formats for specific submissions and corresponding implementation timetables.

“Specifically, this guidance discusses (1) the submission types that must be submitted electronically, (2) the timetable and process for implementing the requirements, and (3) criteria for waivers of and exemptions from the submissions in electronic format requirements,” the draft explains…