C
Dear all,
I wanted to understand the process for PMA application for Medical device(s) (Class III) and wanted to know where does Protocol Agreement fit in the stages of IDE, Clinical investigation , HDE and PMA and so on? FDA being a new thing for me I am just too confused reading all the detailed FDA regulations and guidelines. I am getting more confused than ever.....as I read more.....Please help me find solution.
Any place where i can read in simple words the processes involved with FDA approvals....(presentations, articels related to this issue)
Thank you in advance.
CBAL08
I wanted to understand the process for PMA application for Medical device(s) (Class III) and wanted to know where does Protocol Agreement fit in the stages of IDE, Clinical investigation , HDE and PMA and so on? FDA being a new thing for me I am just too confused reading all the detailed FDA regulations and guidelines. I am getting more confused than ever.....as I read more.....Please help me find solution.
Any place where i can read in simple words the processes involved with FDA approvals....(presentations, articels related to this issue)
Thank you in advance.
CBAL08
