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Premarket Approval (PMA) - is the FDA process of scientific and regulatory review of devices "that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury".
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510(k) application and submission - is the FDA scientific and regulatory approval process of devices that a manufacturer thinks is "substantially equivalent" to a similar device that was on the market prior to May 28, 1976. This is less involved than the premarket approval defined in reference 9.
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