机会均等
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机会均等
A medical device manufacturer conducted a successful randomized IDE clinical trial, but at the time of study closure they decided not to file the Premarket Approval (PMA) application for business reasons. However, five years later, the business climate had improved and the company proceeded with its PMA application. The sponsor knew this unique situation would present significant challenges readying the long closed study sites for the expected FDA BIMO inspections.