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FDA Provides Relief to Medical Device Manufacturers Under UDI
  • Arent Fox LLP
  • USA
  • November 8 2018

The FDA has delayed the date on which it plans to enforce compliance with certain Unique Device Identification (UDI) requirements, prompting a


Consider Playing By This Book's Rules: FDA-MITRE Cybersecurity Guidance
  • Baker Sterchi Cowden & Rice LLC
  • USA
  • October 31 2018

As part of Cybersecurity Awareness Month, we continue our discussion about the FDA’s efforts to help prepare various entities to address


FDA Announces New Efforts to Combat Cybersecurity Threats in Medical Devices
  • Morrison & Foerster LLP
  • USA
  • October 24 2018

FDA is tackling cybersecurity threats head-on and expects industry to do the same. Earlier this month, FDA commissioner Scott Gottlieb, M.D


FDA & DHS Coordinate Efforts to Address Cybersecurity
  • Knobbe Martens
  • USA
  • October 24 2018

The U.S. Food and Drug Administration (FDA) announced an agreement with the U.S. Department of Homeland Security (DHS) to strengthen the partnership


FDA Issues Draft to Update Prior Final Guidance on Premarket Cybersecurity for Medical Devices
  • Barnes & Thornburg LLP
  • USA
  • October 23 2018

The FDA recently issued a draft guidance document titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” The


510(k) Safety and Effectiveness - A Changing Landscape for Punitive Damages?
  • Drinker Biddle & Reath LLP
  • USA
  • October 23 2018

The Central District of California recently issued an opinion that breathes new life into the argument that the 510(k) substantial equivalence


FDA Responds to Device Software Vulnerabilities by Releasing New Draft Cybersecurity Guidance
  • Mintz
  • USA
  • October 22 2018

On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which


Proposed changes to FDA guidance for the content of premarket submissions for management of cybersecurity in medical devices: What you should know
  • Hogan Lovells
  • USA
  • October 19 2018

On October 18, 2018, FDA issued a long-awaited draft revision to its existing guidance "Content of Premarket Submissions for Management of


FDA Issues New Guidance for the Management of Cybersecurity in Medical Devices
  • Crowell & Moring LLP
  • USA
  • October 19 2018

Yesterday, the FDA released draft guidance on the management of cybersecurity in medical devices submitted to the agency for premarket review. Noting


FDA, DHS Increase Coordination Over Medical Device Cybersecurity Risks to Patient Safety
  • Holland & Knight LLP
  • USA
  • October 18 2018

The U.S. Food and Drug Administration (FDA) is moving aggressively in the month of October to continue to raise concerns about cybersecurity risks to