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Premarket Approval (PMA) | FDA

    https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma
    Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a … See more

PMA Application Contents | FDA

    https://www.fda.gov/medical-devices/premarket-approval-pma/pma-application-contents
    An applicant's cover letter should accurately identify the type of PMA submission, i.e., an original PMA, PMA supplement, PMA amendment to a pending PMA or PMA …

PMA Application Methods | FDA

    https://www.fda.gov/medical-devices/premarket-approval-pma/pma-application-methods
    A PMA application involves many volumes of material to be submitted to FDA. The volumes include device description and intended use, nonclinical and clinical studies, case report …

PMA Approvals | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/pma-approvals
    An approved Premarket Approval Application (PMA) -- like an approved New Drug Application (NDA) -- is, in effect, a private license granted to the applicant for …



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