No, a distributor cannot directly apply for FDA certification in the United States. FDA certification or clearance is typically the responsibility of the manufacturer of the product, as they are the ones who are directly involved in the design, production, and labeling of the product. Distributors are typically not involved in the approval process itself but play a key role in the distribution of FDA-approved or cleared products.
Manufacturer Responsibility:
Foreign Manufacturers:
Distributor's Role:
Registration of Establishments:
In summary, while distributors play an important role in the distribution of FDA-regulated products, the actual responsibility for obtaining FDA approval or clearance lies with the manufacturer. Distributors need to ensure that the products they distribute comply with FDA regulations.
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