On October 17, 2012, FDA announced another development in the MDUFA III implementation. The publication of the draft guidance on the eCopy program describes how FDA will initiate implementation once the guidance is finalized.
An eCopy serves as the duplicate for the paper medical device submission. After FDA receives the appropriate submission they will upload the eCopy into the official document repository. In addition to the eCopy, the draft guidance also discusses new technical standards. FDA’s loading system cannot upload eCopies that do not meet these new standards therefore the new requirements become crucial to medical device submissions.
While the draft guidance is not yet official, it is projected to be implemented January of 2013. After guidance becomes final, an eCopy will be required. Comments and recommendations are being accepted by FDA for 30 days. You may submit online commentary here.
For help with your IDE, 510k, PMA submissions, contact us at firstname.lastname@example.org.