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  • srg36 replied to the topic "Cost and Time of Device Clearance/Approval"5 years, 10 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…   Read more»