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No summer vacation for device regulators: an overview of recent legislation and FDA activity, Part II
  • Jones Day
  • USA
  • November 5 2012

In Part I of this Commentary, presented in a separate publication, we summarized some of the new legislation recently promulgated by Congress in the Food and Drug Administration Safety and Innovation Act.


No summer vacation for device regulators: an overview of recent legislation and FDA activity, Part I
  • Jones Day
  • USA
  • November 2 2012

Over the summer, Congress enacted new laws regulating medical devices.


Certain post-approval activities to support submissions to the FDA are now subject to claims of patent infringement
  • Jones Day
  • USA
  • September 20 2011

On August 31, the Federal Circuit significantly restricted the scope of the "safe harbor" provision of 35 U.S.C. 271(e)(1), which immunizes the use of patented inventions in connection with regulatory submissions to the Food and Drug Administration ("FDA").


Is your smart phone an FDA-regulated medical device?
  • Jones Day
  • USA
  • August 3 2011

An enormous number of software applications have been developed for use on handheld computers such as smart phones, tablet computers, and personal digital assistants.