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J12 MAC Transition

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Requests for Authorization of Clinical Trials, IDEs, HDEs and Post-Approval Extension Studies Print

Information about Clinical Trials, Individual Device Exceptions (IDEs), Humanitarian Device Exemptions (HDEs), and Post-Approval Extension Studies is available here:

Decision Diagram

Clinical Trials
Investigational Device Exceptions
Humanitarian Device Excemptions
Post-Approval Extension and PMA Studies

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