FDA updated guidance on its eCopy program for medical device submissions Oct. 10 to clarify its proper usage to help companies submit electronic versions of device applications to the agency.

The revised guidance contains some substantive changes and adds clarifications and additional instructions to the previous final guidance issued on Dec. 31, 2012. (See Also see "FDA Finalizes 510(k), PMA, eCopy Guidances" - Medtech Insight, 7 January, 2013..) Sponsors have been required to submit an eCopy of their submission along with a paper copy since Jan. 1, 2013, Peper Long, CDRH associate director for external relations, told “The Gray Sheet.”

The guidance defines an eCopy “as an exact duplicate of the paper submission, created and submitted on a compact disc (CD), digital video disc (DVD) or a flash drive.” It must be accompanied by a paper copy of the signed cover letter and the complete paper submission.

“While this [eCopy] program has improved the review process by allowing the immediate availability of an electronic version of a medical device submission for review by FDA staff, it may not be yet well understood by all applicants,” Long said.

Therefore, Long said FDA updated the eCopy program guidance and related Web page “in an effort to reduce errors made in submitting an eCopy and address questions raised by applicants.”

She said the major updates included points of clarification, a summary of steps for creating and submitting an eCopy, more examples to demonstrate the different technical standards and changes to the PDF required technical standards with regards to embedded attachments/attributes and security settings.

Broader Acceptance Of Secured PDFs

The new eCopy software will accept PDFs with some security settings and those with embedded attachments or attributes, unlike the previous software which rejected these types of documents.

“The rejected PDF files were due to embedded attachments or attributes that the applicant did not intentionally embed and of which they were unaware. Accordingly, in order to streamline the eCopy processing, we have updated our software to not reject PDFs with embedded attachments or attributes,” the guidance states.

However, FDA adds that applicants should not intentionally embed attachments to PDF files, since those attachments are not compatible with its repository and could lead to FDA missing information during the review. The guidance also includes an explanatory note stating, “Do not confuse embedded attachments or attributes with hyperlinks or bookmarks, as these are very different. Hyperlinks and bookmarks are not only permitted, but are also encouraged.”

In addition, PDFs with security settings that protect the content from modification will now be accepted. But, those that are password-protected will continue to be rejected.

New And Improved Instructions

Jean Bigoney of regulatory consulting firm Nu Device Consulting LLC, who submits eCopies for her clients, said one of the problems with the previous guidance was lack of information, which she felt FDA has addressed in the revised guidance.

She said that the additional instructions regarding the document numbering system are welcome additions. The guidance says, “Volume (if applicable) and PDF numbering start over with each new eCopy rather than continuing from a previously submitted eCopy.”

This means that the file name of the first PDF document in the updated draft of an eCopy starts with “001.” Similarly, the file name of the first document in each volume (which is an electronic folder) must start with “001,” the second document should start with “002” and so on. This information was provided in the old guidance, but is now more clearly delineated and prominently located in the updated guidance.

The new guidance also states that companies should resubmit their entire eCopy in response to an FDA hold notification, which means there was a technical error in the submission, and “not just corrected files or folders.”

The attachment explaining the technical standards for eCopies has been expanded and contains more explanatory screen shots.

Unclear If Software Bugs Fixed

FDA created a program called eSubmitter that is supposed to package the documents so that they meet all of the technical requirements, including the document numbering requirements.

But it doesn’t work very well, Bigoney said.

“If the eSubmitter will package something that is guaranteed to pass the validation I would love to use the eSubmitter, but I have been prevented from doing so at least three times because of issues that I feel exist with the eSubmitter. I’ve been stuck numbering everything by hand,” said Bigoney, who is disappointed that there has been no announcement that the bugs have been fixed.

FDA did not respond by press time to an inquiry about problems with eSubmitter and whether they have been fixed.

Bigoney said the last time she used eSubmitter was July, but added that broadening the types of PDF files accepted would not have solved the problems she experienced. Other medical device consultants publicly expressed frustration with the program in March on the “Medical Devices and FDA” group forum on professional social media site LinkedIn.

If the submission does not meet the technical requirements, it is put on hold by FDA. To get around that, Bigoney emailed her client’s submission directly to FDA in November 2012.

“The validation procedure at FDA was obviously flawed so the reviewer contacted me and said ‘Don’t tell anybody, but just email it to me. Just email me your eCopy.’ So [the reviewer] bypassed the document mail center. Otherwise, the document mail center gives it to the guys in the [information technology] department. They try to validate it, it doesn’t validate and you’re in this endless loop,” Bigoney explained.

Updated eCopy Guidance Clarifies FDA’s Electronic Submission Program

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