Author: Suzanne Broussard, PhD
Up to 7% of premarket submissions are placed on eCopy Hold. At a recent public workshop, FDA experts provided multiple tips to device manufacturers to avoid this trap and get their submission accepted the first time. Although the workshop focused on spinal device premarket reviews, most of the tips are relevant for all device manufacturers submitting premarket submission applications.
Sometime in the near future, FDA will roll out this new electronic Submission Template and Resource (eSTAR) portal making eCopy obsolete. However, FDA urges manufacturers to take advantage of its current guidelines and resources to make their documents as clean as possible and ready for review right now.
The currently used eCopy is a digital version of the traditional paper submission that reviewers interact with, like a paper copy. Failure to meet all the technical requirements of eCopy results in the eCopy Hold, which resets the review clock upon resubmission and can be costly to manufacturers.
According to Zane Wyatt, Premarket Tools and Template Developer for FDAs Office of Regulatory Programs, the 7% of FDAs premarket submissions placed on eCopy Hold could have been avoided by taking the following steps.
Note that the eCopy electronic version of your medical device submission created and submitted on a CD, DVD or flash drive does not increase or decrease the type or amount of data included in a submission to support clearance or approval.
The FDA processes the eCopy onto a secure internal database that has upload restrictions, thus the strict technical requirements. If the submission fails the technical requirement for intake and archival, the submission is placed on eCopy Hold until all the technical requirements are met that allow the reviewers access to the document.
The eCopy guidance document provides details on:
The eCopy Validation tool is a downloadable software that can help compile all documents into the correct format, however, the electronic documents still need to be physically sent to the FDA document center.
FDA Tip to Applicants:
“It is recommended that you use the eCopy Validation Module to check the final eCopy on the CD, DVD, or flash drive before submitting it to the FDA in order to identify any errors or hidden files that may cause an eCopy to fail the eCopy Loader used by FDA.
(eSTAR) – 510(k) submissions through eSTAR are currently in a pilot program. The dynamic PDF submission template will provide many advantages including:
Employing these three tips to your premarket submission could save your organization valuable time in the review process with regulatory authorities. FDA is moving towards a fully electronic submission that is dynamic, responsive, and flexible in its development of eSTAR. Until eSTAR is fully available for all premarket submissions, these tips from FDA experts may come in handy.
Preparing all the technical documents required for premarket submission will require much more effort.
Criterion Edge’s team of medical writers are experts at preparing the technical, safety, and regulatory documents required to get to the premarket submission phase. Feel free to reach out to us for a free consult.
Tags: estar, fda, Medical Device, premarket submission
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