Looking for a Premarket Approval (PMA) Template or checklist

B

Ballroom Blitz

#1
Hi
Does anyone have the following:
1)a PMA template (redacted)
2)PMA checklist
they can share?
This is for a combination product, no software sections.

Our company has never done a PMA before so I am starting from scratch and its been 5 years since I worked on an original PMA.

Any help would be appreciated.
 
B

Ballroom Blitz

#4
I was looking for a template someone created for a submission, table of contents
She'll for a PMA.
The FDA links to guidance are already obvious to me ! So that doesn't answer my question.
I can understand an inability to share a table of contents, even if redacted
 

Ronen E

Problem Solver
Staff member
Super Moderator
#5
I was looking for a template someone created for a submission, table of contents
She'll for a PMA.
The FDA links to guidance are already obvious to me ! So that doesn't answer my question.
I can understand an inability to share a table of contents, even if redacted
Well, sometimes you don't get exactly what you're looking for, even in Elsmar. If I had such a template that I could share, I would have shared it. Hopefully someone else will be more instrumental.

I shared the 2 links because:
1. Personally I prefer the source as my checklist, not something someone I don't know created for purposes I don't necessarily know (might be right for them but wrong for me).
2. You noted that it's been 5 years since you authored an original PMA and the guidance document is newer than that so I thought you might be unaware of it.

Peace,
Ronen.
 

Top Bottom