The Device Submission eCopy Requirements

By Allyson B. Mullen –

Now that the eCopy program is well underway, it might be a good idea to review how the program works and consider a few of the common pitfalls.  Although nearly a year has passed since the final guidance document for the eCopy Program for Medical Device Submissions (the “eCopy Guidance,” we previously blogged on the guidance here) was issued, the glitches are still being worked out. 78 Fed. Reg. 102 (Jan. 2, 2013).  Earlier this month, FDA issued a revised version of the eCopy Guidance, which incorporates several minor changes to clarify the processing and technical standards for eCopies based on FDA’s experience to date with the program.  eCopy Guidance at 1.

An eCopy is “an exact duplicate of the paper submission,” and not an electronic submission.  Id. at 2.  Generally, the key things to remember when preparing an eCopy are:

• The eCopy must be submitted on a CD, DVD or flash drive along with the paper copy of the submission;
• The eCopy must be delivered together with a signed cover letter which states, either, that “the eCopy is an exact duplicate of the paper copy,” or “the eCopy is an exact duplicate of the paper copy except [specifying all differences]” (each, an “eCopy Statement”);
• If the submission is submitted by a party other than the applicant (e.g., law firm, consultant, etc.), the eCopy cover letter must be signed by the submitting party (the law firm, consultant, etc.) rather than the applicant (e.g., manufacturer);
• The eCopy must meet FDA’s technical requirements (see, eCopy Guidance Attachment 1), which can be an issue with certain media, such as flash drives that come pre-loaded with various files;
• The electronic files should be primarily in pdf format; and 
• The electronic files must be named in a specific fashion with a prefix (e.g., “001_”, VOL_001_”) depending on whether the submission comes in volumes.

It can be easy to have your submission put on eCopy hold if the eCopy does not precisely meet the requirements of the eCopy Guidance.  For example, if the files do not exactly follow FDA’s naming scheme or the submitter forgets the eCopy Statement in the cover letter, the submission can be placed on eCopy hold.  It is important to remember that FDA will not accept a submission, for which an eCopy is required, until a valid eCopy has been received.  Id. at 12.

An eCopy is required for nearly all medical device submissions, including 510(k)s, de novo petitions, PMAs, IDEs, HDEs, and pre-submissions. Id. at 3-4.  Even when an eCopy is not required by law (e.g., Master Access Files, 513(g)s and CLIA Categorization submissions), FDA still “strongly encourages” that you include an eCopy with your submission.  Id. at 5.  A trap for the unwary submitter is that the filing instructions in several of FDA’s existing guidance still instruct filers to send a certain number of hard copies rather than hard copies and an eCopy.  For example:

• FDA’s 2006 Guidance Document “Real-Time Premarket Approval
  Application (PMA) Supplements,” (the “Real-Time Guidance”) states that three copies of the supplement should be submitted to FDA for review, but makes no reference to one of those copies being an eCopy.  Real-Time Guidance at 8; and 
• FDA’s Draft Guidance “Medical Devices: The Pre-Submission Program and Meetings with FDA Staff” (the “Pre-Submission Guidance”) states that the submitter should send three hard copies of the Pre-Submission to FDA for review, and goes on to say that FDA only “strongly encourages [the submitter] to submit an electronic copy in which case [the submitter] may submit only two (2) hard copies.”  Pre-Submission Guidance at 12.

The statements in these other guidance documents are no longer operative in light of the eCopy Guidance, which requires that an eCopy be submitted with all PMAs and Pre-Submissions.  Revised eCopy Guidance at 3-4.  Therefore, submitters should remember that the eCopy Guidance trumps these other guidance documents and just because the submission-specific guidance does not articulate that an eCopy is required, FDA will still place the submission on eCopy hold until it is received.