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srg36 replied to the topic Cost and Time of Device Clearance/Approval in the forum Clinical Trials for Medical Devices 6 years, 11 months ago
The division of the company that I work for only submits 510k applications, and the FDA cost associated with submitting a 510k is $10,566. In 2016, the average time to get 510k clearance was 177 days. Just recently, my company received 510k clearance for a device 65 days after submitting the 510k. However, this came as a shock to us, because it usually takes much longer than this.
https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm452519.htm
emergobyul/resources/research/fda-510k-review-times-research
ryortho/breaking/fdas-510k-clearance-performance-remains-average