Here's an option to consider. Don't do it. I was in a similar place as you. For a past consulting client (class I sterile consumer direct), I had a service supplier (Registrar Corp) take on the Registration and Listing (R & L) responsibilities for the client. As part of the R & L services, the supplier became the firm's official correspondent with USA FDA. eMDR submissions (form 3500A) was included in the base services cost. This made sense for my client as we expected a handful of MDRs per year. Disclaimer: I am an independent consultant and not affiliated with Registrar Corp.