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What are the Costs and Timeline for FDA Certification of Medical Devices in the USA?
Category：行業(yè)資訊 Date：2024-09-19 16:41:07 Author: Source:
The timeline for FDA certification also varies; a 510(k) submission typically takes 3 to 6 months, while PMA (Premarket Approval) can take a year or more due to more extensive data requirements. Additional factors like the complexity of the device and any required clinical trials can further influence both costs and timelines.

The costs for FDA certification of medical devices can vary significantly based on the device classification. For Class I devices, the fees may be relatively low or even exempt from user fees. For Class II devices, costs can range from $5,000 to $10,000 for the 510(k) submission, while Class III devices can incur higher fees, often exceeding $20,000.8(1).jpg

The timeline for FDA certification also varies; a 510(k) submission typically takes 3 to 6 months, while PMA (Premarket Approval) can take a year or more due to more extensive data requirements. Additional factors like the complexity of the device and any required clinical trials can further influence both costs and timelines.

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