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Compliance Alert for Non-US Companies
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By Carl Alletto, Regulatory Consultant, OTech, Inc.
The FDA has issued the final rule to amend its regulations pertaining to the registration of foreign establishments. The final rule requires that foreign establishments whose products are imported or offered for import into the United States must register with FDA and also must identify a United States agent. The final rule is effective February 11, 2002. A United States agent is defined as a person residing or maintaining a place of business in the United States whom a foreign establishment designates as its agent. This definition excludes mailboxes, answering machines or services, or other places where an individual acting as the foreign establishment's agent is not physically present.
Generally speaking, before this final rule was issued, a foreign establishment could, but was not required to register with FDA. However, it was mandatory for companies to list devices. This difference in registration and listing requirements confused some foreign establishments and led to non- compliance with the listing requirement. Additionally, the lack of registration information on foreign establishments sometimes made it difficult for FDA to determine the source of specific imported products, particularly products that were impure, counterfeit products, or products whose safety or efficacy had not been established.
The final rule requires that the agent assist FDA in communications with the foreign establishment, to respond to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and to assist FDA in scheduling inspections of the foreign establishment. The final rule also authorizes FDA to provide information or documents to the United States agent if FDA is unable to contact the foreign establishment directly or expeditiously. Foreign establishments have the discretion to give their United States agents' additional tasks and may always contact FDA directly, with or without their United States agents.
The final rule does not require the United States agent to be responsible for legal issues surrounding the product's admission into the United States. In general, FDA does not intend to hold the United States agent responsible for violations of the act committed by a foreign establishment. If a foreign establishment violates the act, FDA would pursue action against that foreign establishment. Examples of instances where FDA might take action against the United States agent would be where the agent submitted false information to FDA or where the agent and the foreign establishment were effectively the same entity.
Each foreign establishment must designate only one United States agent. OTech can be your designated US agent or we can assist you in this process. Designated agents are identified by completing the Initial Registration Device Establishment Form 2891 (if you have previously never registered with FDA) or adding the name of the US agent on the Annual Registration of Device Establishment Form 2891(a) which is sent to every FDA registered firm once per year. The completed forms should be sent to FDA before the end of February 2002.
Also, it is required that the foreign establishment or the United States agent reports changes in the United States agent's name, address, or phone number to FDA within 10-business days of the change.
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