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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 as of February 11, 2001. See related article.
The agent will 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.
OTech will function as an US agent, as defined and required by the FDA final rule.
The agent will:
- Assist the 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.
- Assist FDA in scheduling inspections of the foreign establishment.
- If the FDA is unable to contact the foreign establishment directly or expeditiously, the agent will facilitate information or document exchange between the FDA and the foreign establishment.
- The agent will file either the Initial Registration Device Establishment Form 2891 (if you have previously never registered with FDA) or file the Annual Registration of Device Establishment Form 2891(a).
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