FDA makes changes for device and emergency use authorizations

07/30/2013 | Clinica

The FDA will provide a single submission number for investigational device exemptions and emergency use authorizations beginning Aug. 18, which will allow the agency to track multiple studies and milestones more efficiently and will streamline the entire process. Subsequent submissions to an IDE or EUA will be assigned to the appropriate study and will be classified as supplements, reports or amendments. Under the new system, companies should ensure that they include only one submission reason per IDE submission.

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