Tag: Export Compliance

Exporting an Unapproved Investigational Device from the US in Support of a Clinical Trial in a Foreign Country.

Over the past few weeks I’ve had several conversations with manufacturers and consultants alike regarding the export of an Unapproved Investigational Device for use in a Clinical investigation to be conducted entirely outside the United States.   One of the first comments I get asked: does the FDA have jurisdiction? While the answer is easy, Read More …