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Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissio

Posted Oct 17 2012 12:00am
The purpose of the draft guidance is to explain the new electronic copy (eCopy) program for medical device submissions. The draft guidance describes how FDA plans to implement the eCopy Program under the Federal Food, Drug,and Cosmetic Act (the FD&C Act).
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