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Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Mintz - Health Care Viewpoints

FDA 2018 Year in Review (and a Few Thoughts on 2019)

Mintz - Health Care Viewpoints on

As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...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

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