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Results: 1-10 of 2,351

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns
  • Hogan Lovells
  • USA
  • January 17 2018

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations


Food, Drug and Device Law Alert - FDA Issues Amended Final Guidance on Medical Device Accessories
  • Barnes & Thornburg LLP
  • USA
  • January 2 2018

The Food and Drug Administration (FDA) issued several medical device guidance documents late last year, including an amended version of a previously


The Highs Celebrating the Ten Best Prescription DrugMedical Device Decisions of 2017
  • Reed Smith LLP
  • USA
  • December 28 2017

Ending the year on a high note is one thing that the blog tries to do - with the top ten drugdevice product liability decisions of the year


US FDA Issues New Guidance for Digital Health
  • Baker McKenzie
  • USA
  • December 26 2017

With the increasing prevalence of digital health products and technology, the US Food and Drug Administration (US FDA) has launched several new pieces


FDA 2017 Year in Review: Refining Medical Device Pathways and Introducing Pilot Programs to Promote Quality
  • Mintz Levin
  • USA
  • December 26 2017

This is the third installment of our year-in-review series covering major developments at FDA. While the previous two installments, which can be found


FDA Issues New Draft Guidance on “Least Burdensome” Principles for Medical Devices
  • Drinker Biddle & Reath LLP
  • USA
  • December 21 2017

On December 15, the U.S. Food & Drug Administration (FDA) issued “The Least Burdensome Provisions: Concept and Principles: Draft Guidance for Industry


FDA Releases Digital Health Guidance to Spur Innovation
  • Cooley LLP
  • USA
  • December 19 2017

On December 7th, the Food and Drug Administration (FDA) announced the release of a much-anticipated suite of guidance documents that loosen the


Is Your Software a Medical Device? FDA Weighs-in with New Draft Guidances
  • Reed Smith LLP
  • USA
  • December 19 2017

On December 8, 2017 - nearly a year after President Obama signed into law the 21st Century Cures Act ("Cures Act") - the Food and Drug Administration


The Use of Real-World Data and Real-World Evidence in Medical Product Development
  • K&L Gates
  • USA
  • December 15 2017

In this episode, Erica Jackson discusses recent guidance from the Food & Drug Administration (FDA) on the consideration of real-world data and


New Legislation Increases Access to Medical Products for Military Applications
  • Hogan Lovells
  • USA
  • December 12 2017

Today, the President signed new legislation that gives the Department of Defense (DoD) new opportunities to advocate to FDA for expedited development