School bells have sounded the death knell of summer across the land. But as we’ve noted before, the U.S. Food and Drug Administration (FDA) didn’t take much time off to enjoy surf and sand. The agency capped a busy season last week by issuing a new guidance aimed at investigational review boards (IRB), clinical investigators, and sponsors when determining if an investigational device exemption (IDE) application or an investigational new drug application is warranted.

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