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Newsletter - December 14, 2017
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FDA’s Relaxed Software Regulations Opens Doors to The Digital Doctor
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This week FDA described its heavily hands-on approach for the approval of “Artificial Pancreas” to highlight how FDA reviewers could play an active role in approval of innovative new products. There are several lessons for other developers in this story and notes of caution as well. Read More

FDA Measures for Early Feasibility Studies for Devices Bears Fruit

Over the last few years, FDA created the Early Feasibility Studies (EFS) program to encourage developers of new medical devices to conduct such studies in the US under IDEs instead of other countries. An EFS is a small clinical trial on an early prototype of a Class III medical device... Read More

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