FDA has released eSubmitter Version 3. This software allows the user to create reposts, such as MRD or Corrections & Removals, and format them for transmission to FDA Electronic Gateway.
The plan is to allow use of eSubmitter Version 2 until May 2018, when it will be disabled.
Ombu recommends immediate update to Version 3 to ensure all the manufacturers’ internal processes are updated and working before the end of Version 2.