To get along with tech sector, FDA must "stay in its lane"

09/25/2015

There is bound to be friction when innovators rub elbows with regulators. That is true of medical device manufacturers, who must navigate FDA requirements to bring their products to market. But as frustrating as the process might be, they will grudgingly acknowledge that it's part of doing business in a heavily regulated space. It's altogether different for companies that do not have a history of dealing with FDA and are attempting to enter the medtech space, as is the case with the tech sector. For businesses that have pledged allegiance to the "innovate or die" ethos, FDA can be viewed as an overbearing obstacle to progress. In the middle of that scrum is Paul Kalb, who leads the national healthcare law practice at global law firm Sidley Austin (Chicago).
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