December 12, 2023

Difficulty Submitting Part 806 Report via FDA’s ESG Gateway

If for various reasons you are unable to submit your FDA Part 806 Report of Correction or Removal via FDA’s ESG Gateway, then another option is to have a third party submit your 806 report using the third party’s active ESG production account. For example, due to submitters’ various ESG account issues of late, my firm has had clients approach us to submit their ESG submissions using my firm’s valid account.  We’d be glad to do that for you too if you’d like to reach out to me further.

Regarding format, two typical choices regarding Part 806 reports are to use the eSubmitter, or to prepare the Part 806 report the traditional way with a word processer using a proven format.  My firm’s Part 806 format has been proven to lead to reliable recall closure concurrence from FDA and I’d be glad to discuss that further with you as well.  Or, if you already have an eSubmitter output file for your Part 806 report and the various attachments and data are sensibly associated with the body of the report via proper document publishing, labels and/or bookmarks such that the FDA recall coordinator can easily navigate the document, then you could also submit it that way directly to the recall coordinator’s contact point.