Smith Associates

Experienced Consultants Specializing in Regulatory Affairs:

• 510(k) Submission (Pre-Market Notification)
• PMA (Pre-Market Approval)
• IDE (Investigational Device Exemption)
• GMP (Good Manufacturing & Quality Assurance)
• Medical Marketing Services

United State Agent Services

21 CFR 807.40(b) requires a foreign establishment to designate a United States Agent to act as their official correspondent. 

The Food and Drug Administration defines the role of an United States Agent as:

• Assisting FDA in communications with the foreign establishment.
• Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States.
• Assisting FDA in scheduling inspections of the foreign establishment.
• Registering and updating the establishment and its products.
• Maintaining an office address in the United States.