The Food and Drug Administration has made public draft guidance on its new eCopy program for electronic submission of information on medical devices.
In a notice published on Oct. 17, FDA seeks comment on the draft guidance, which explains how it plans to implement eCopy, before starting work on a final version. “The inclusion of an eCopy is expected to improve the efficiency of the review process by allowing for the immediate availability of an electronic version for review rather than relying solely on the paper version,” the agency notes.
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