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.
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