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Results: 1-10 of 66

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


Attempt to repeal medical device tax fails again
  • Arnall Golden Gregory LLP
  • USA
  • May 28 2014

The U.S. Senate once again lost an opportunity to repeal the 2.3 medical device tax this past week when procedural maneuvers were used to stop an


FDA proposes expedited access program for devices addressing Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions
  • Arnall Golden Gregory LLP
  • USA
  • May 14 2014

On April 23, 2014, the U.S. Food and Drug Administration (FDA) announced a proposed new program to provide earlier access to high-risk medical


CDRH issues Warning Letter for unlawful product promotion
  • Arnall Golden Gregory LLP
  • USA
  • May 13 2014

While we don't see quite as much Food and Drug Administration enforcement against medical device companies as we see for pharmaceutical firms in the