US Agency
As of 1976, Amendments to 21CFR have required that registered foreign facilities appoint a US agent to act as a communications and regulatory liaison.
The FDA states:
"§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."
However, with "communications" and regulatory compliance between the FDA and manufacturers now being fully "electronic", it is logical to elect your electronic submissions vendor to be your US agent.
Regulatory Compliance notices for SPL or eCTD submission are the majority of FDA communications to most firms. Missing important due dates for Regulatory submissions, or delaying communication of Regulatory notices can be costly by causing unnecessary customs holds, losing precious customers, or leading to FDA warning letters.
US agency duties should be no mystery.
Saxon Interglobal offers reliable, cost-effective US agency services that appropriately complement Regulatory Compliance SPL , eCTD and Medical Device requirement submissions.
As of 1976, Amendments to 21CFR have required that registered foreign facilities appoint a US agent to act as a communications and regulatory liaison.
The FDA states:
"§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."
However, with "communications" and regulatory compliance between the FDA and manufacturers now being fully "electronic", it is logical to elect your electronic submissions vendor to be your US agent.
Regulatory Compliance notices for SPL or eCTD submission are the majority of FDA communications to most firms. Missing important due dates for Regulatory submissions, or delaying communication of Regulatory notices can be costly by causing unnecessary customs holds, losing precious customers, or leading to FDA warning letters.
US agency duties should be no mystery.
Saxon Interglobal offers reliable, cost-effective US agency services that appropriately complement Regulatory Compliance SPL , eCTD and Medical Device requirement submissions.