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Results:1-10 of 57

Six ways for data-driven medical device companies to implement effective privacy and security measures
  • Arnall Golden Gregory LLP
  • USA
  • August 17 2015

The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers


Off-label promotion, state-level injury lawsuits, and preemption
  • Arnall Golden Gregory LLP
  • USA
  • June 23 2015

The issue of preemption in product liability cases involving medical device products continues to evolve. Recently, the U.S. Court of Appeals for the


Former senior executives indicted for illegal marketing of a medical device
  • Arnall Golden Gregory LLP
  • USA
  • May 27 2015

Two former senior executives were indicted with violations of the Food, Drug, and Cosmetic Act relating to the introduction of adulterated or


FDA and CMS announce joint task force on LDTs
  • Arnall Golden Gregory LLP
  • USA
  • April 22 2015

The U.S. Food and Drug Administration (FDA) recently announced the formation of an interagency task force with the Centers for Medicare and Medicaid


Reaching a state of comfortably numb: FDA intends to relax enforcement for certain types of medical devices
  • Arnall Golden Gregory LLP
  • USA
  • March 2 2015

When one reads the final guidance, "Medical Device Data Systems MDDS, Medical Image Storage Devices, and Medical Image Communications Devices," the


FDA announces comment opportunity on CDRH documents
  • Arnall Golden Gregory LLP
  • USA
  • January 21 2015

The Food and Drug Administration (FDA) has announced the opening of a docket dedicated to receiving comments on guidance documents that the Center


FDA guidance on home use devices
  • Arnall Golden Gregory LLP
  • USA
  • August 12 2014

On August 5, the Food and Drug Administration (FDA) issued a guidance entitled "Design Considerations for Devices Intended for Home Use." The


FDA issues guidance for mobile medical applications
  • Arnall Golden Gregory LLP
  • USA
  • October 11 2013

The number of mobile medical applications for use on smartphones and tablets is growing rapidly as more and more app developers release new products


A medical device company’s guide to the new unique device identification (UDI) system
  • Arnall Golden Gregory LLP
  • USA
  • October 2 2013

On September 24, 2013, the Food and Drug Administration (FDA) issued a Final Rule regarding a new way companies must label and classify devices


Medical device tax repeal: delayed, but not forgotten
  • Arnall Golden Gregory LLP
  • USA
  • September 12 2013

The Patient Protection and Affordable Care Act ("PPACA") (P.L. 111-148) included a medical device excise tax of 2.3, which took effect in January