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What are the Costs Associated with Appointment of the U.S. FDA Agent?

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What are the Costs Associated with Appointment of the U.S. FDA Agent?

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The Food and Drug Administration estimates that the cost to hire a U.S. FDA Agent as required under the Regulations may be between $2,000 and $1,200 USD per year. It is estimated that a foreign facility that tries to register itself will spend between ten and thirty hours trying to register. This time-cost will be much less, as little as thirty minutes, if the foreign facility uses its U.S. FDA Agent to register the facility.

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The Food and Drug Administration estimates that the cost to hire a U.S. FDA Agent as required under the Regulations may be between $2,000 and $1,200 USD per year. It is estimated that a foreign facility that tries to register itself will spend between ten and thirty hours trying to register. This time-cost will be much less, as little as thirty minutes, if the foreign facility uses its U.S. FDA Agent to register the facility.

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