Hairmax® Blog

FDA 510(k) Medical Device Clearance: Efficacy or Just Safety?

The 510(k) submission is the primary mechanism by which medical devices are accepted to the market in the US. The FDA requires data to back equivalence claims, descriptive data and performance data to support this type of submission. There is a general misperception that the FDA clears medical devices for marketing only based on proof of the safety. That assumption is not correct in all cases, as there is also...

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