Challenge

A company had successfully CE marked a novel lung function device, and the next step in the commercial strategy was to obtain 510(k) clearance to market in the USA.

This was a complex submission that required careful planning in order to expedite the approval process while at the same time maximizing its use over a number of potential measurement parameters.

Solution

Our medical device regulatory consultant worked closely with the client’s product development and clinical teams to develop a strategy that balanced timelines and cost against the delivery of a marketable product that offered competitive advantages over existing products on the market. The initial approach involved taking a pre-submission route to gain feedback from the FDA on the proposed strategy.