What does a plaintiff have to prove to win a case against the manufacturer of a...
What does a plaintiff have to prove to win a case against the manufacturer of a premarket-approved medical device?
Homework Answers
FDA finds devices to be substantially eqalent (SE) and then can be marketed in US. Submitter should compare their devices to one or more similar legally marked devices and make substantial equalance claim. This order clears the device for commercial distribution..
A510(K) is a premarket submission to FDA to demonstrate that the device to be marketed is safe and effective.
So the plaintiff have to prove that the premarket approved medical device does not have substantially equavalance claim or A510(K) to win the case.
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What does a plaintiff have to prove to win a case against the
manufacturer of a...
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