Double Check Flash Drive Before Burning eCopies, FDA Says

Devicemakers submitting eCopies with their submissions should double check their eCopy media before burning to make sure any preloaded files are removed, an updated FDA guidance says.

“Certain brands of media, particularly flash drives, come preloaded with files that may lead to your eCopy failing the loading process.” These should be deleted before burning eCopies to the media, the guidance advises. The agency notes that devicemakers can choose to burn their eCopies to a CD, DVD or flash drive.

The Oct. 10 guidance was released at the end of the budget stalemate between Congress and the Obama White House that shuttered much of the federal government for much of the month.

The revised document updates a final eCopy guidance that took effect Jan. 1 and requires eCopy submission for most types of device applications. The new policy, mandated in the FDA Safety and Innovation Act, doesn’t eliminate the need for a paper copy of submissions but requires devicemakers to include an eCopy along with the paper version.

The update also notes that there are no special considerations for submitting an eCopy for a “review hold notification” versus an eCopy for an original submission. “Each eCopy is its own entity and the same technical standards in Attachment 1 apply to each eCopy,” the FDA says. As such, the volume and PDF numbering start over with each new eCopy, and devicemakers should not provide previously submitted information in a response to a hold notification, the agency adds. An eCopy in response to a 510(k) hold notification should only include the response content.

Devicemakers should respond to eCopy hold notifications within 180 days or the FDA might consider the submission to be withdrawn, the updated guidance says. Companies are advised to allow time for mail delivery and eCopy processing. “You risk withdrawal and closure of your submission if your response is mailed very close to or at 180 days,” the guidance says.

As noted in the earlier version of the guidance, eCopies should be accompanied by a cover letter and the paper copy of the submission. The FDA recommends that submitters check eCopies against an online validation tool before filing them.

Attachment 1 in the updated guidance includes an overview on “basic steps for developing an eCopy” and provides details on the individual steps. For example, it cautions devicemakers not to confuse a company cover letter with the Center for Devices and Radiological Health’s Form FDA 3514 Premarket Review Submission Cover Sheet.

The structure of an eCopy depends on the size of the submission and may be presented as either a volume-based or nonvolume-based submission, the guidance says. The FDA recommends a nonvolume-based eCopy for most small or less-complex submissions.

While devicemakers can provide a single PDF for the entire eCopy submission, the PDF file may not exceed 50 megabytes, the guidance says. Companies are reminded to include bookmarks or hyperlinks in large files, which can take longer to open and search and may otherwise present challenges for FDA reviewers.

However, attachments to the PDF files should not be embedded, as these are not compatible with the FDA’s repository and could be overlooked during the review, the guidance says. Password-protected PDFs are another problem for reviewers and will result in a hold, the guidance adds.

Attachment 1 of the updated guidance also provides a variety of visual examples of the content that should go into eCopy submissions.

The FDA demands good documentation and it wants you to submit paperwork electronically. Good Documentation Practices will help you archive all that you need. Order your copy and make sure that all of your paperwork is always in order.