FDA to Medical Device Submitters Using WebTrader: Remove Your Files Now

A January 11, 2013 email sent by Michael Fauntleroy, Program Manager, FDA ESG, is warning those using the WebTrader for electronic submissions to delete their inboxes, or risk losing all documents contained within them in the future.

January 2013 | AssurX, Inc.

A January 11, 2013 email sent by Michael Fauntleroy, Program Manager, FDA ESG, is warning those using the WebTrader for electronic submissions to delete their inboxes, or risk losing all documents contained within them in the future. WebTrader is a supposed to be a low-volume submission tool, however, some companies have apparently been using the system as a file server or archival system.

FDA states that the misuse of the system has resulted in significantly lower performance for all other account holders. They suggest removing the submission records and storing it either locally or on a company-wide network.

The email also listed the number of “offending” accounts:

  • 1 account has more than 3000 documents
  • 9 accounts have more than 2000 documents
  • 34 accounts have more than 1000 documents
  • 96 accounts have more than 500 documents
  • 763 accounts have more than 100 documents
  • 2833 accounts have more than 20 documents
  • Note: Each submission transmission has 3 – 4 documents associated with it. e.g. 20 documents in an Inbox translates to 5 -6 submissions.

According to FDA, “…ESG’s WebTrader functionality is provided to the industry by FDA as a low cost alternative to send submissions to FDA. The WebTrader Inbox provides the users a view of submissions sent to FDA and receipts and Acknowledgements received from FDA. This inbox should not be used as a storage place for your Receipts and Acknowledgements – once you receive Receipts and Acknowledgements for your submissions you should:

  • Download Receipts and Acknowledgements and save them to your local machine
  • Delete records from your WebTrader Inbox

Following these steps will ensure faster display of the Inbox for you, other ESG users and increase overall performance of the system.”

The email also states “The account owners that have more than 2,000 documents in their WebTrader Inboxes will be receiving an email with a zip file of their messages. We will delete these documents from your Web Trader Inbox at the FDA immediately. This policy is being re-implemented on a permanent basis.”

In the closing paragraph of the email, written in red ink, the FDA sternly warns: “On February 1, 2013 we will start deleting documents in Web Trader account Inboxes without notice. Any Web Trader Inbox with more than 20 documents in it will be cleaned starting February 1, 2013. Once the Inbox is cleared of documents (Receipts and Acknowledgements) they cannot be retrieved so WE STRONGLY ADVISE YOU TO DOWNLOAD RECEIPTS AND ACKNOWLEDGEMENTS FROM YOUR INBOX after each transmission.”

Clearly, those who have hundreds or thousands of documents should probably consider upgrading to another type of eMDR submission system.