The US Food and Drug Administration (FDA) has published a new draft guidance with “both binding and nonbinding provisions” related to electronic submissions for medical devices.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, 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.
Electronic submissions will be required for 510(k) submissions, De Novos, Premarket approval applications (PMAs), modular PMAs, product development protocols, investigational device exemption (IDE) applications, humanitarian device exemption applications, emergency use authorizations, and certain investigational new drug applications and biologics license applications, FDA says. And although they’re not required, FDA recommends all Q-submissions be submitted in electronic format.
A copy of the draft guidance can be accessed here.