FDA Consensus Standard for PMA (Pre-Market Approval)

Q

QAengineer13

Quite Involved in Discussions
Hi,

I need some guidance from your previous PMA submission where you have used FDA consensus standard.

1) For the PMA - Do we fill the FORM FDA 3654 or Declaration of Conformity for the particular the standard ( Following the Guidance Doc Recognition and use of consensus standards)

2) If the standard is horizontal and if its set of Requirements and no testing/ acceptance criteria for Pass /fail - ( eg, 62304, Auto11 etc) do I just submit the matrix ( I would really appreciate, if you can share the matrix structure)

Thank you!
 
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