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When does FDA require a post-approval study (PAS)?

April 26, 2017fda PAS post-approval require study

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When does FDA require a post-approval study (PAS)?

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FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application to help assure continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of the approved device.