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The 510(k) Process Does Involve a Relevant Safety Review, Despite What You May Have Read or Heard

Presented to the American Bar Association Section of Litigation

November 4, 2016

This article about the effective use of evidence for medical devices, including the use and impact of 510(k) clearance data, and the role of the FDA in medical device product liability litigation, was prepared for the American Bar Association (ABA) Section of Litigation's Pharmaceutical, Medical Device and Biotech Subcommittee of the Products Liability Committee. 

The article was written by Adam Masin and Sarah Westby as part of a seminar on Current Issues in Pharmaceutical, Medical Device and Biotech Litigation.

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