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alexandrabuga replied to the topic Cost and Time of Device Clearance/Approval in the forum Clinical Trials for Medical Devices 7 years, 1 month 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 $2,642
2018 standard rate for PMA is $310, 764 and for small business is $77,691I do think its fair for small businesses to receive a discounted rate. It will be interesting to see what the rates will be moving forward in 2023.
https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm452519.htm
