Hello Anon,
I use the same process of Declaration of Conformity (DoC) for PMA submission as I do 510(k) submissions. The use of recognised and voluntary standards are similar just the level of detail in a PMA is more. Though as you mention including a lot more in the DoC for a 510(k) - I do the same - so the level of detail provided in a PMA is the same as a 510(k). For a Supplier Declaration of Conformity (DoC) for me this only is provided when a supplier, contractor, or external entity is conducting something as part of final product release. Then I get their supporting documentation to provide, i.e. ISO certs or other certification.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 08-Jul-2022 09:06
From: Anonymous Member
Subject: PMA Declaration of Conformity SDoC & DoC
This message was posted by a user wishing to remain anonymous
Hi,
I do a lot of 510(k)s and I'm now working on a PMA Class III IVD submission. Is DoC and SDoC the same process for PMA as 510(k)? I looked at the guidance "Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices" but I've included a lot more in my DoC for my 510(k) then what that guidance is giving. In addition, we did in-house testing and third party, would we request a SDoC from third party to include in our DoC? Any elaboration on the guidance would be helpful. Thank you