US AGENT FOR NON-US MEDICAL DEVICE COMPANIES SERVICE

On February 11, 2002, the FDA issued a new regulation (21 CFR 807.40) that requires non-US companies that market medical devices in the US to appoint a US Agent with the FDA.

The US Agent's responsibilities:

• To assist the FDA in communicating with the non-US company
• To respond to questions concerning the non-US company’s products that are imported or offered for import into the United States
• To assist the FDA in scheduling inspections of the non-US company

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