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FDA Letter to File

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0% found this document useful (0 votes)
44 views9 pages

FDA Letter to File

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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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:

● Your proper user settings and permissions


● Know who has Administrative access
● Upload all products and all relevant product information
● Check that the proper hierarchy structure is set up
● Set up Legal Entities
● Set up the manufacturing facility information
● Identify the Submission organizers or Submission Writers that will be used for this
submission
● If using a Submission Writer, Identify the Submission Writer template and verify that the
template ‘approved’ status

Select the Appropriate Registration


From your dashboard, select Registration, All Registrations
1. Search the registration that you want to amend to create the Letter to File. You can
search by name or number, or you can sort any column to search.

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.

Amending The Registration


1. Select the drop down arrow next to the Registered button and choose Amending.
You may get a pop up message asking you if you’re sure you want to transfer the certificates
that exist in the current version of the registration to the new version of the registration. Since
this is only a documentation change, select Yes, Continue.

Select the Appropriate LifeCycle State


1. To select a LifeCycle Stage: In the Details tab of the Registration, you can edit the
Lifecycle Stage or a Sub Type Life Cycle Stage and select an appropriate designation
depending on your company process.
2. You can choose Registered for the Lifecycle Stage and Letter to File as the Sub Type as
an example.

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.

4. Repeat these steps for each file you want to include.

Routing for Internal Approval


Once everything is finished, you are ready to send the submission for approval. You may or may
not have the option to select the approver(s). But this is where you would add them. Check
with your administrator for permission access.
Select route for approval and then select the name(s) of who you wish to review the
submission. Save. This submission is now routing and cannot be edited again unless the
approver rejects the approval. You will receive an email that your submission is now waiting for
approval.

Reviewing the Registration Record


Certificates
1. Verify that your certificate(s) are linked to the submission by clicking on the Certificates
tab. Here you will see a list of linked certificates, if any were previously linked.

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.

4. Enter the date information and continue.


5. After you complete the date section, select the certificate you want to link.

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.

2. Choose the status of the file you selected.


3. A comment is optional for Approved, but for Rejected or Withdraw, a comment is
required to continue. You may also receive an email with a one-time verification code to
proceed.

4. Once that is complete, your Letter to File will be linked to the registration record.

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