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