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James salmon

06/02/21 6:19 PM

#30084 RE: Mcol52 #30083

It does not cost that much to actual file, please fact check before posting;


FDA 510(k) Device Review User Fee – $3,108 or $12,432 (2021)

The FDA charges to review the entire 510(k) application, the product, and the business that is applying for the FDA 510(k) clearance approval. There are two rates for the device review; $3,108 for any business that sold less than $100 million in the last tax year, and $12,432 for any business that sells more than $100 million in the last tax year