Hello Anon,
You do need to submit your design control procedure(s) as part of the Module including applicable design control documentation. The guidance you reference is the one to be using as well as the other PMA guidance documents. The amount or type of design and development records submitted with the PMA submission depends on the product, the documentation, and what information needs to be presented - this is submission and device dependent. However, a PMA submission is quite detailed so the level of documentation can be substantial. The requirements, regulations, and guidance are found in 21 CFR 820, 21 CFR 814, and various guidance documents
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma#:~:text=A%20Premarket%20Approval%20(PMA)%20application%20is%20a%20scientific%2C%20regulatory,the%20approval%20of%20PMA%20application.. You might want to have some expert involvement or at least have support on the Module being put together.
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 19-Sep-2022 20:02
From: Anonymous Member
Subject: Design Control Documentation for Modular PMA
This message was posted by a user wishing to remain anonymous
We are submitting our 4th PMA module for our medical device which will include design controls. Reading the 2003 FDA guidance "Quality System Information for Certain Premarket Application Reviews", it seems like FDA requires a procedure to be submitted in the PMA submission which covers all the aspects called out in the procedure. However, do we need to also provide evidence on how we met those aspects during our design and development i.e. phase review approval?
Can someone assist in clarifying what all should be included in this submission for design controls and also provide the regulation/guidance which dictates the requirement?