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Can a foreign company submit an IDE/Is a U.S. Sponsor required?

COMPANY foreign IDE sponsor submit
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Can a foreign company submit an IDE/Is a U.S. Sponsor required?

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A foreign company cannot sponsor an IDE; they must have a U.S. agent who acts as the sponsor (see 21 CFR 812.18(a)). The U.S. agent must fulfill all the responsibilities of a sponsor identified in the IDE regulation.

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