Guest post by Lisa Voronkova, Founder & CEO of OVA Solutions and author of the "Hardware Bible."
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Every founder building a medical device googles "510(k) cost" at some point. If you are new to this: a 510(k) is the most common FDA pathway for getting a medical device cleared for sale in the US. You demonstrate that your device is substantially equivalent to something already on the market (a predicate device), and the FDA lets you sell it. About 3,000 of these clear every year.
What you find when you google the cost is a r...
