Andrew Campbell

Andrew Campbell

Faegre Baker Daniels

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FDA Draft Guidance Outlines Regulatory Requirements for 3D Printed Medical Devices

On May 10, 2016, FDA released a much-anticipated draft guidance (the “Guidance”) concerning medical devices that incorporate additive manufacturing (AM) technologies, a category which includes 3D printed devices. AM...more

5/13/2016 - 3D Printing Additive Manufacturing Draft Guidance FD&C Act FDA Manufacturers Medical Devices Popular

Supreme Court Reinforces Need for Robust Adverse Event Reporting Process

On June 23, 2014, the United States Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, leaving in place the Ninth Circuit's en banc decision permitting a failure-to-warn claim against a pre-market approval (PMA)...more

6/27/2014 - Failure To Warn Medical Devices Medtronic SCOTUS

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