Tuesday, May 14, 2013

FDA's New eCopy Submission Requirement for 510(k) Medical Device Approvals

Effective January 1, 2013, the U.S. Food and Drug Administration (FDA) will only review a premarket submission if it has an electronic copy (eCopy) that has been validated by FDA's eCopy loading system. An eCopy is defined as an exact duplicate of the paper submission, created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive.

This means that 510(k)'s and applications for Premarket Approval (PMA's) which are not submitted to FDA in both hard copy and eCopy format will be rejected. An eCopy is accompanied by a paper copy of the signed cover letter and the complete paper submission. The signed eCopy statement must say: THIS ECOPY IS AN EXACT DUPLICATE OF THE PAPER COPY.

Failure to submit these two additional items will delay the review, and, therefore, required approval, of your medical device with FDA. For detailed information on FDA's new eCopy program, read FDA's final guidance: eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff

For more information on medical device compliance with the FDA, contact:

Peter Quinter, Esq.
Chair, Customs and International Trade Law Group
Shareholder, GrayRobinson, P.A.
1221 Brickell Avenue, Suite 1600
Miami, Florida 33131

Direct:  305-416-6960

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