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An FDA “curriculum” helps guide medical device startups through regulatory maze

By July 21, 2014No Comments
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fda-gov-product-regulate

It’s  tough for medical device companies to get that stamp of FDA approval, but the labyrinthine regulatory pathway certainly doesn’t help things. Regulators want to change that:

“…we learned that the delivery of new therapies to patients can be accelerated if medical device innovators — including entrepreneurs and university students and faculty — understand FDA’s regulatory processes,” FDA researcher Francis Kalush wrote recently.

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