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How much does FDA certification cost?

FDA certification is mainly divided into "FDA registration" and "510K certification". Only FDA registration is required for exempt products, and 510K certification is required for non-exempt products in addition to FDA registration. To determine whether your product is exempt, you can consult us for free.

[FDA registration] Fees mainly include "FDA official fees" and "registration Service fees". FDA's official fees vary from year to year (and will rise from year to year), to more than $5,000 in 2021. Service fees are charged by consultants and vary.

[510K certification] the fee is mainly technical document writing service fee, but also the consulting institution, generally about 50,000 yuan.

How much does FDA certification cost?

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