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Rule on electronic device submission proposed by FDA
9/13/2018

A draft rule on device submission, which would require a single electronic submission and identify mailing addresses on a new website, has been issued by the FDA in a move to ease the regulatory burden on the medtech industry. "FDA considers eCopies, submissions copied to a CD, DVD, or flash drive and mailed to FDA, and eSubmissions to be submissions in electronic format," the agency said.

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