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Results: 1-10 of 891

Top 5 steps for medical device manufacturers to operationalize their cybersecurity programs
  • Kaye Scholer LLP
  • USA
  • May 25 2015

In an age where the critical infrastructure of almost every government, organization, and network depend on technology, cyber issues have quickly


FDA issues guidance documents on how it considers balancing premarket and postmarket data collection during PMA reviews in a bid to accelerate the approval of new breakthrough devices
  • Loeb & Loeb LLP
  • USA
  • May 7 2015

The regulator explains how it determines when it's appropriate to increase reliance on postmarket collection to reduce the extent of premarket


Mobile apps offer opportunity, challenges for health & beauty field
  • Shook Hardy & Bacon LLP
  • USA
  • April 1 2015

As devices plug more people into the "Internet of Things," there is a growing overlap between the world of smartphones, tablets and software, and the


Increased FTC enforcement as FDA deregulates low-risk health IT devices
  • Morgan Lewis & Bockius LLP
  • USA
  • March 25 2015

In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement actions against companies that make misleading promotional claims


Navigating litigation and tort liability risks for mobile health and health IT applications
  • Arnold & Porter LLP
  • USA
  • February 18 2015

In the last ten years, mobile applications ("apps") have become an integral part of daily life for people throughout the world. Manufacturers have


FDA issues final guidance eliminating regulatory controls on medical device data systems, imaging storage devices, and imaging communications devices
  • Ropes & Gray LLP
  • USA
  • February 11 2015

On February 9, 2015, the United States Food and Drug Administration (FDA) issued a final guidance document describing the Agency's intention not to


New guidance documents from FDA seek to clarify regulation for wellness devices and medical device accessories
  • Hall Render Killian Heath & Lyman PC
  • USA
  • February 10 2015

On January 20, 2015, the Food and Drug Administration (the "FDA" or "Agency") published two draft guidance documents designed to fulfill promises it


FDA finalizes guidance on medical device data systems
  • Hall Render Killian Heath & Lyman PC
  • USA
  • February 10 2015

On February 6, the Food and Drug Administration (the "FDA" or "Agency") released a finalized guidance (the "Guidance") informing the public that the


FDA proposes electronic distribution of prescribing information
  • Baker & Hostetler LLP
  • USA
  • January 15 2015

Drug manufacturers may no longer be required to distribute prescribing information on paperwith limited exceptionsand instead may have


Another ediscovery front?
  • Reed Smith LLP
  • USA
  • December 29 2014

On December 18, the FDA published its proposed rule for replacing the venerable package insert with "electronic" prescribing information. The cite is