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What is an FDA US Agent? And why do you need one?

If you are interested in learning more about FDA US Agent requirements, please read our blog: ➤ https://medicaldeviceacademy.com/fda-... If you would like a quote for our FDA US Agent services, please email us: ➤ [email protected] If you leave a comment or question below this video, please inform Becca in your email, and she will give you a $50 discount (i.e., $550 for initial registrations and $400 for renewals). If you know a medical device company outside the USA that needs an FDA US Agent, or they aren't happy with its current agent, please share this video. Here are some of the questions we answered in the video: Does the FDA have agents? What does a US agent do for the FDA? What is the FDA US agent ID? How do I become a US-registered agent? What are the applicable regulations requiring companies outside the USA to identify a US Agent? Subpart C—Procedures for Foreign Device Establishments § 807.40 Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States. b) Each foreign establishment required to register under paragraph (a) of this section shall submit the name, address, and phone number of its United States agent as part of its initial and updated registration information in accordance with subpart B of this part. Each foreign establishment shall designate only one United States agent and may designate the United States agent to act as its official correspondent. (1) The United States agent shall reside or maintain a place of business in the United States. (2) Upon request from FDA, the United States agent shall assist FDA in communications with the foreign establishment, respond to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and assist FDA in scheduling inspections of the foreign establishment. If the agency is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the United States agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment. (3) The foreign establishment or the United States agent shall report changes in the United States agent's name, address, or phone number to FDA within 10-business days of the change. One of the comments we had during the video in the chat indicated that the US Agent Regulations was: 21 CFR 207.69. This is actually the regulation for US Agents for Drug Manufacturers, while Medical Device Academy is only a US Agent for Device Companies: Subpart F—Miscellaneous § 207.69 What are the requirements for an official contact and a United States agent? (a) Official contact. Registrants subject to the registration requirements of this part must designate an official contact for each establishment. The official contact is responsible for: (1) Ensuring the accuracy of registration and listing information; and (2) Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications. (b) United States agent. Registrants of foreign establishments subject to this part must designate a single United States agent. The United States agent must reside or maintain a place of business in the United States and may not be a mailbox, answering machine or service, or other place where a person acting as the United States agent is not physically present. The United States agent is responsible for: (1) Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications; (2) Responding to questions concerning those drugs that are imported or offered for import to the United States; (3) Assisting FDA in scheduling inspections; and (4) If FDA is unable to contact a foreign registrant directly or expeditiously, FDA may provide the information and/or documents to the United States agent. FDA's providing information and/or documents to the United States agent is equivalent to providing the same information and/or documents to the foreign registrant.