PMS template for FDA submission (De novo submission for a Class II IVD)

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shimonv

Trusted Information Resource
#2
Hello Martahv78,
To my knowledge, PMS is not a submission requirement for de novo application. But let's see what the others say..
 

Watchcat

Trusted Information Resource
#3
Not a requirement for any type of FDA premarket FDA submission, as far as I know. Perhaps FDA has made PMS a condition of approval? In that case, it has most likely required a PMS study.
 
#7
My question is whether or not Post Market surveillance (plan or preliminar results) must be submitted to the FDA for an initial De Novo Submission
 

shimonv

Trusted Information Resource
#8
Formally, it is not a requirement. If it can support your claims you may want to consider submitting it as a supporting document.
 
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