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Who is a Sponsor (as defined by the FDA) for an IDE?

Sponsor is a person or other entity that initiates but does not actually conduct the investigation.

An entity other than an individual (e.g., a corporation or an agency) which uses one or more of its own employees to conduct an investigation that it has initiated is considered to be a sponsor, not a sponsor-investigator, and the employees are considered to be investigators. The sponsor of an IDE must be located in the United States (see 21 CFR 812.18).