The Food and Drug Administration has made public draft guidance on its new eCopy program for electronic submission of information on medical devices.
In a notice published on Oct. 17, FDA seeks comment on the draft guidance, which explains how it plans to implement eCopy, before starting work on a final version.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.
Submission of an eCopy currently is voluntary, but the Food and Drug Administration Safety and Innovation Act requires electronic submission after final guidance is issued.
“The eCopy program is not intended to impact (reduce or increase) the type or amount of data the applicant includes in a submission to support clearance or approval,” according to the notice. “An eCopy is defined as an exact duplicate of the paper submission, created and submitted on a compact disc, digital video disc, or in another electronic media format that FDA has agreed to accept, accompanied by a copy of the signed cover letter and the complete original paper submission.”
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