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  • alexandrabuga replied to the topic "Cost and Time of Device Clearance/Approval"5 years, 10 months ago

    Yes as @srg mentioned the 501k rates. Just to add ot the conversation as per Medical Device User Fee Amendments to the FDA Reauthorization Act (MDUFA IV) through 2022: 2018 standard rate for 510k is $10,5666 and small business is…   Read more»