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Foreign agent for FDA-approved medical device manufacturers

The FDA’s Center for Devices and Radiological Health lists
The Weinberg Group as a U.S. agent for non-U.S. companies selling
into the U.S. market. As a U.S. agent, The Weinberg Group

• supports foreign medical device manufacturers in establishing business in the US
• assists foreign establishments in communicating with the FDA and vice versa
• on behalf of and in cooperation with foreign establishments, responds to Agency questions concerning the foreign establishment's products that are imported or offered for import into the United States; and
• assists the FDA in scheduling inspections of foreign establishment

To learn more, contact Michael Swit, Vice President. +1 760.633.3343 or email michael.swit@weinberggroup.com

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