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FDA Is Allowing Big Pharma To Use 70's Data To Pass Inspections
2 months ago
4
Medical devices are like the wild west. in order to get onto the market, the manufacturer just has to show that that device is substantially equivalent to a device that's already on the market. What's disturbing about it is that these manufacturers can piggyback off of devices that entered the market before 1976 and that predicate device can be a device that was recalled from the market. Caleb Cunningham is joined by Kelsey Stokes, a medical device attorney with the law firm of Fleming, Nolan and Jez, to explain more.
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