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


Quite Involved in Discussions
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.
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
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