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Software › De Novo Standard of Review

Dorsey & Whitney LLP

FDA Testing New Approaches for Review of Digital Health Device Applications

Dorsey & Whitney LLP on

On January 7, 2019, FDA Commissioner Scott Gottlieb announced significant updates to the FDA’s pilot Software Pre-Certification Program, sometimes referred to more broadly as a Digital Health Pre-Certification Program...more

Mintz - Health Care Viewpoints

FDA 2017 Year in Review: Refining Medical Device Pathways and Introducing Pilot Programs to Promote Quality

Mintz - Health Care Viewpoints on

This is the third installment of our year-in-review series covering major developments at FDA.  While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more

McDermott Will & Emery

Precedential Cloud Victory in Michigan Court of Appeals

McDermott Will & Emery on

On October 27, 2015, a three-judge panel sitting for the Michigan Court of Appeals unanimously affirmed a lower court decision finding that the use of cloud-based services in Michigan is not subject to use tax in Auto-Owners...more

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