FDA approval process for medical device

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William55401

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#2
It depends. What is your product? What claims are you making? The approval path (and typical timeline) will be a function of the device classification. Novel high risk devices require clinical studies. Devices similar to what's already on the market have a more direct path to FDA clearance. There is no one size fits all answer here.
 
#3
Hello Shruti,
Apologies to being late,
It is very important that which medical device you are going to certify by the FDA and in which class it is going to classify.
 
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