The U.S. Food and Drug Administration (FDA) has issued initial guidance on its general requirements for the electronic formatting of pre-submissions and submissions for medical devices.
The Guidance, “Providing Regulatory Submissions for Medical Devices in Electronic Format,” provides a general overview of FDA’s plan to implement requirements consistent with a 2017 amendment to the Federal Food, Drug, and Cosmetic Act. That amendment requires parties to submit documentation in support of a device approval electronically.
Specifically, the Guidance details the Agency’s plans to implement these requirements, including the types of submissions subject to these requirements. The Guidance expressly identifies premarket notification submissions (510(k)), evaluation of automatic class III designation requests (De Novos applications), pre-market approval applications (PMAs), and investigational device exemption (IDE) applications as medical device approval routes requiring electronic submissions.
The Guidance also notes that the FDA will issue separate guidances in the future detailing electronic submission requirements for each approval route. But the Guidance is vague on timing of these additional guidances, noting only that their release will be “sequential, allowing for an eventual phased implementation.”