The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "eCopy Program for Medical Device Submissions,'' for industry and FDA staff. The purpose of the draft guidance is to explain the new electronic copy (eCopy) program for medical device submissions.
The draft guidance, Document number 1797, describes how FDA plans to implement the eCopy Program under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). 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. This draft guidance is not final nor is it in effect at this time.
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.
Although you can comment on any guidance at any time, to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 16, 2012.
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