Author: Suzanne Broussard, PhD  | October 12, 2020

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.

1. Use the newest eCopy guidance document published April 27, 2020: 

eCopy Program for Medical Device Submissions – Guidance for Industry and Food and Drug Administration Staff 

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: 

• Submission types that require an eCopy 
  • Premarket notification submissions (510(k)), including third party 510(k)s
  • Evaluation of automatic class III designation petitions (de novos)
  • Premarket approval applications (PMAs), including Transitional PMAs
  • Modular PMAs 
  • Product development protocols (PDPs)
  • Investigational device exemptions (IDE) submissions 
  • Humanitarian device exemptions (HDEs) submissions 
  • Emergency Use Authorizations (EUAs) 
  • Certain investigational new drug applications (INDs)
  • Certain biologics license applications (BLAs)
  • Q-submissions
• Other submission types not subject to the eCopy legislation for which eCopies may be submitted 
• Processing steps for eCopy 
• Devices regulated by CBER 
• Technical Standards of the eCopies 
  • Document content (original, supplement, amendment, or report) 
  • Create company letter head per specific requirements 
  • Determine volume-based or non-volume-based structure 
  • Specifics on PDF requirements (naming convention, root level, Adobe Acrobat version, no embedded attachments, no security settings, size limit of 50MB) 
  • Use of non-PDFs 
  • Package preparation and mailing to the Document Control Center (CCC) 

2. Consider using the FDAs eSubmitter-eCopies Tool (voluntary) to format your eCopy content. 

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. 

3. Use eCopy Validation on the FDA website using the most recent version (July 20, 2018). 

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: 

• Content mirrors the reviewer’s Smart Template 
• Integration and elimination of guidance documents 
• Automation and Integrated Databases 
• Guides 
• No special software install or training 
• Works on mobile and Macs, and is free to use 

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.