FDA Letter to File
FDA Letter to File
A letter to file is internal documentation justifying that design changes do not need a new
regulatory 510(k) or PMA submission. The manufacturer will take responsibility to document
that the design change is still in compliance with the original submission requirements.
Before beginning this process, be sure to have the following already set up in Rimsys:
2. Be sure that the submission is at the Registered status by checking the Working Status
column.
3. Once found, click on the registration number, not the check box, of that line item.
Using the Documents Tab to attach Letter to File Documentation to the Registration Record.
1. Link documents by selecting the Documents tab, then the Link Documents button.
2. If you already have a Letter to File document that you want to use, you can link or
attach it within this section.
3. Either scroll through the list of documents or search for it individually. Once you locate
it, click the checkbox in the name column to add it and then save your work.
2. If the certificate you are looking for is not linked, search for it, select the checkbox, and
then select save to link it.
Routing the Registration for Approval
3. Once the certificate is linked, select the drop down arrow next to Amending and select
Register.
6. Choose who you want to route the change to for approval and then select Save.
7. You are now successfully routing version 2 of the registration for approval.
Approving the Registration Record
1. Return to your dashboard and find the submission that is pending approvals. Select it
and it will take you to the Request List for that submission.
4. Once that is complete, your Letter to File will be linked to the registration record.