US FDA Agent Registration Service


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The U.S. Food and Drug Administration (FDA) requires foreign establishments that manufacture, process, pack, or store FDA-regulated products to have a designated U.S. Agent. The U.S. Agent serves as a…

US FDA 510 (k) Registration


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US FDA 510 (k) Registration Features included in your subscription: What is FDA 510(k) Clearances?  Section 510(k) of the Food, Drug and Cosmetic Act  Requires device manufacturers who must register…

The US FDA Establishment Identifier (FEI) number


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The US FDA Establishment Identifier (FEI) number The FDA Establishment Identifier (FEI) number is a unique identifier assigned by the U.S. Food and Drug Administration (FDA) to regulated establishments. This…