FDA Issues Draft Guidance Regarding the New Electronic Copy (eCopy) Program for Device Submissions

By Carmelina G. Allis –

FDA has issued a draft guidance document to explain how FDA plans to implement the new eCopy program under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which was added by the Food and Drug Administration Safety and Innovation Act (“FDASIA”).  When implemented, this program will allow the immediate availability to FDA reviewers of an electronic version of the submission instead of relying solely on the paper version for review.

Section 745A(b) to the FDC Act requires that FDA issue a guidance document implementing the requirement that “presubmissions and submissions for devices under section 510(k), 513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 520(m), or 564” of the FDC Act, and for devices regulated by CBER under Section 351 of the Public Health Service (“PHS”) Act, and “any supplements to such presubmissions or submissions, [] include an electronic copy of such presubmissions or submissions.”  The statute permits FDA to include in the guidance document the “standards for the electronic copy” and the “criteria for waivers of and exemptions from the requirements [under Section 745A].”

An eCopy as an exact duplicate of the paper submission.  It may be submitted on a CD, a DVD, or in another electronic media format accepted by FDA.  It must be accompanied by a copy of the signed cover letter and the complete original paper submission.  If a submission is received by FDA without an eCopy or the eCopy submission does not meet the standards provided in the guidance, FDA will put the application on hold (that is, the review clock will not start) until a valid eCopy is submitted.

Once the FDA finalizes this draft guidance document, FDA will require the submission of an eCopy for the following applications: 510(k)s, de novo requests, PMAs, PDPs, IDEs, HDEs, HUDs, and pre-submissions (formerly known as “pre-IDEs”).  In addition, any subsequent submission, such as amendments, annual reports, or supplements, must be submitted under the eCopy program.  This requirement regarding subsequent submissions will apply even if the original submission was submitted to FDA prior to the implementation of the eCopy program.

FDA has specifically exempted compassionate use and emergency use IDEs and Emergency Use Authorizations (“EUAs”) from the eCopy requirement.  In addition, FDA plans to allow waivers for device submissions that are subject to licensure under the PHS Act (e.g., BLAs, INDs) that are submitted entirely as electronic submissions to CBER.  CBER has already issued guidance documents for applicants who choose to submit electronic submissions.

The criteria and specifications required for an eCopy described in the draft guidance document are not being implemented by FDA until the document is finalized.  You may submit written comments regarding this draft guidance to FDA’s Division of Dockets Management (via http://www.regulations.gov) at any time.  But to ensure that your comments are considered prior to finalizing the draft guidance, you should submit them by November 16, 2012.