Electronic Device Submissions: FDA Drafts Guidance

Regulatory NewsRegulatory News | 25 September 2019 |  By 

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to the FDA Reauthorization Act of 2017 (FDARA), the US Food and Drug Administration (FDA) on Wednesday published a new draft guidance with “both binding and nonbinding provisions” related to electronic submissions for medical devices.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

Electronic submissions are 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.

The draft also notes that certain types of IDE submissions will be exempt from the electronic submission requirements, including compassionate use requests and "adverse event reports (all types, e.g., serious, malfunctions, etc.)." FDA also says that it may identify and recommend formats for electronic submission for Master Access Files, 513(g) Requests for Information and Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization requests and CLIA Waiver Applications.

“The required format(s) for the specific submissions and corresponding timetable(s) for implementation will be specified in these individual guidances,” FDA says, noting that waivers, if available, will also be discussed in the individual guidance documents that are forthcoming.

Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance


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