On December 31, 2012 the guidance, “eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff" was issued as an official guidance document. The guidance provides step-by-step instructions on how to make submissions for medical devices to FDA using the new eCopy format. Yet to anyone attempting to issue a submission to FDA after January 1st utilizing a strictly paper format, it was quickly learned that this wasn’t a typical FDA guidance document. FDA responded to those “paper only” submissions with an eCopy hold notification; in essence, not received.
This guidance, in fact, contains a blend of guidance and law. As stated by FDA, selected sections of “this document [are] not subject to the usual restrictions in FDA’s good guidance practice (GGP) regulations, such as the requirement that guidances not establish legally enforceable responsibilities.” Per section 745A(b) of the FD&C Act, added by section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA), Congress (i.e., the Legislative Branch or the lawmakers) has granted authorization to FDA (i.e., part of the Executive Branch, or the law executors) to implement the statutory eCopy requirement. These eCopy standards are mapped out, along with actual guidance sections, in the 25 page document.
Overall, the document direction is clear and easy to follow. eCopy is defined in the guidance as “an exact duplicate of the paper submission created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive.” The submitter is, however, still expected to send at least one full paper copy of the submission and a signed cover letter (wet ink or electronic signature). The eCopy concept and its intended platform are critical to understand. Although the guidance suggests utilizing the new eSubmitter format as the template for the submission, the link to the eSubmitter on the FDA’s website is not an active gateway to those making eCopy submissions to CDRH. However, the eSubmitter link is active for submission made to CBER.
The guidance further provides direction regarding which submission types require an eCopy and which are exempt. A reference table, located on page six of the document, details which types of submissions require the use of the eCopy format along with those that may use the eCopy voluntarily. It’s important to note:
- Due to the potentially urgent nature of compassionate use IDE submissions, emergency use IDE submissions, and all emergency use authorizations of medical products they are exempt from the mandate to use the eCopy process, although it is encouraged by FDA.
- All other submissions (including, but not limited to 510(k), PMAs, IDEs, HDEs, and such supplements like annual progress reports or protocol amendments) are now required by law to be submitted to FDA using the new eCopy format.
As noted in the guidance, an eCopy is submitted simultaneously with the paper submission(s) via traditional methods (e.g., conventional mail, FedEx, etc.). Upon receipt at FDA, it will be determined if the eCopy passes the loading process. If the eCopy fails the loading process, the sender will receive an eCopy hold notification. In responding to an eCopy hold, the sender will need to provide a revised cover letter that states a replacement eCopy is being provided as well as a replacement eCopy (CD, DVD, or flash drive).
The sender should pay close attention to Attachment 1, in particular, the cover letter requirements. Without the inclusion of one of the two statements, as listed in the guidance, in the cover letter, the submission will be returned with an eCopy hold notice.
This guidance took many sponsors by surprise. It does not seem the law sections went through the typical review process whereby it is opened for public comment prior to being implemented into law. Additionally, correcting an eCopy hold was challenging working to make corrections and rapidly learn the system while under the gun to meet a deadline.
Finally, it would seem even the FDA is experiencing some bumps in the road. Since the implementation of the new eCopy process incorrect dates on submission receipt notices from the FDA have been reported or a submission number inadvertently forgotten by the FDA. Fortunately, the FDA contacts have been helpful navigating sponsors through this new process.
Have you made a submission using the eCopy Program yet? Do you have any thoughts on the new guidance? Please share your experiences and comments with us.
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