FDA 510(k) consultants are specialized professionals who help medical device manufacturers navigate the complex process of obtaining FDA clearance for their products. A 510(k) submission is a premarket notification that demonstrates a device is safe and effective by showing it is substantially equivalent to a legally marketed predicate device https://s3.dualstack.us-west-1.amazonaws.com/types.of.lawyers/regulatory-gap-analysis-510k.html .
