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QUOTED. 9 October 2019. John Laschinger.

Executive Summary

John Laschinger – a former US FDA cardiac devices medical officer who is now cardiac chief medical advisor for device-maker W.L. Gore & Associates – offered tips to manufacturers on how best to work with the agency. Check out his advice here.

"The most important advice is that the FDA is very open to innovation. They want you to come to them early. They want you to come to them often. They want to interact with you and then really work with you to make sure that whatever device you're working on is the best possible device for patients. And really the best way to achieve that is by working cooperatively with the FDA to attain those goals." – John Laschinger, cardiac chief medical advisor, W.L. Gore & Associates

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