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Saturday, July 07, 2018 10:10:36 AM
In most cases, applicants will eventually submit one or more formal applications to FDA, such as an Investigational Device Exemption (IDE), De Novo, 510(k), or Premarket Approval (PMA). The review of each of these applications will be expedited to minimize review times. The regulatory standard of demonstration of reasonable assurance of safety and effectiveness still applies.
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