Newly finalized guidance from the US Food and Drug Administration further clarifies the agency’s approach toward electronic submissions of premarket notifications, which will become mandatory late next year.
The guidance document, “Electronic Submission Template for Medical Device 510(k) Submissions,” is dated 22 September and was initially issued in draft form in September 2021. It’s part of an ongoing effort to encourage electronic submissions required under the FDA Reauthorization Act of 2017 (FDARA)
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