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FDA Form 3500A MEDWATCH Network13

FDA Form 3500A MEDWATCH Network13

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[Music] the PMA process wasn't necessarily intended to protect device makers but there was a Supreme Court case in 2008 that was regal versus Medtronic and it was determined at that time that the if the device had gone through the gold standard and the clinical trials that the company had done their best to make sure that the product was safe that's had implications in that space ever since 2008 in that the device companies have been able to avoid litigation by citing that case and saying that their device went through pre-market approval and so they should have the same protections

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