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RockoTaco

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RockoTaco

Re: None

Thursday, 06/06/2019 6:11:26 PM

Thursday, June 06, 2019 6:11:26 PM

Post# of 140510
Foreign companies/studies
Can a foreign company submit an IDE/Is a U.S. Sponsor required?
A foreign company cannot sponsor an IDE; the company 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 regulations.
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