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FDA to Create New Digital Health Unit
  • Knobbe Martens
  • USA
  • June 16 2017

The FDA has announced that it will create a new unit responsible for overseeing digital health products. According to Bakul Patel, the Associate


FDA Announces New Initiatives to Regulate Digital Health Technologies
  • Holland & Knight LLP
  • USA
  • June 15 2017

FDA Commissioner Scott Gottlieb, MD, posted a blog today announcing new FDA initiatives re: regulation of digital health technologies to be piloted


Medtronic’s Recent Interactions with the FDA
  • Knobbe Martens
  • USA
  • June 15 2017

It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and


FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices
  • Hogan Lovells
  • USA
  • June 9 2017

On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating


FDA Extends the UDI Compliance Date for Certain Class I and Unclassified Devices
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • June 8 2017

With the deadline for compliance with the unique device identification systemi (UDI system) requirements for certain Cass I and unclassified devices


Future of FDA Regulation of Digital Health
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • June 7 2017

The 21st Century Cures Act includes substantial changes to the FDA’s regulation of medical devices. Bethany Hills discusses the impact on digital


Filling in the Gaps on Medical Device Cybersecurity
  • Hogan Lovells
  • USA
  • June 6 2017

On 18 and 19 May 2017, the Food and Drug Administration (FDA), in collaboration with the National Science Foundation (NSF) and the Department of


FDA - Postmarket Management of Cybersecurity in Medical Devices
  • Baker Sterchi Cowden & Rice LLC
  • USA
  • June 5 2017

It seems almost impossible in today’s world to escape our dependence on technology. From the minute we wake-up in the morning, we access news reports


Clinical trials in the USA
  • Perkins Coie LLP
  • Global, USA
  • June 5 2017

A structured guide to clinical trials in the USA


How FDA’s Program Alignment Initiative Will Impact Industries: An Insider’s Perspective
  • Arent Fox LLP
  • USA
  • May 26 2017

In his first major announcement since taking office, FDA Commissioner Scott Gottlieb, M.D. Finalized a major reorganization plan that had been under