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Medical Devices / Regulatory Affairs

FDA Proposes Overhaul of Device Premarket Submission Requirements

Sept. 13, 2018

In an effort to improve the efficiency of premarket submissions of devices, the FDA issued a proposed rule to replace requirements for multiple copies of submissions with a single electronic format submission.

The changes would apply to 510(k) submissions, investigational device exemption applications, premarket approval applications and humanitarian device exemption applications, as well as submissions for CBER-regulated devices.

The agency said the new requirements, if approved and implemented, would make the premarket submission program more effective by reducing burdens and expenses. It would also give the agency immediate access to an electronic version for review, as opposed to relying only on paper submissions.

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