FDA - Annual Report Submission Format and QMS updates

[QAengineer13]

Dear members,

I have two requests:

1. Can you help me with the format for annual report submission to FDA ( template , examples)

2. Template which can summarize the changes made to QMS after submission to FDA.

Any help or input will be much appreciated!

Thanks

 

[MIREGMGR]

FDA doesn't expect very many annual reports anymore. The only one that's immediately familiar to me is in regard to manufacture/repair/installation of radiation emitting devices, though there probably are others. What report are you asking about?

Along the same lines, I don't understand "template which can summarize the changes made to QMS after submission to FDA." In my range of experience, FDA normally doesn't need or want to know about changes to an Establishment's QMS. What requirement are you wanting to satisfy?

 

[QAengineer13]

FDA doesn't expect very many annual reports anymore. The only one that's immediately familiar to me is in regard to manufacture/repair/installation of radiation emitting devices, though there probably are others. What report are you asking about?

Along the same lines, I don't understand "template which can summarize the changes made to QMS after submission to FDA." In my range of experience, FDA normally doesn't need or want to know about changes to an Establishment's QMS. What requirement are you wanting to satisfy?

Thanks for your response. I apologies for not making it clear ,the QMS update /change submission will be part of our PMA re-submission.

Regarding annual report, if FDA doesn't require it, can you guide me on the format for documenting the addition to Technical file/ Design dossier about the changes which doesn't affect the safety and/or effectiveness but its part of product change management.

Thank you!