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Doing Business in North America (Volume 1 - United States)
  • Miller Canfield PLC
  • USA
  • April 23 2016

In choosing to conduct business in the United States, businesses based in other countries should keep in mind that business entities are formed under

FDA Still Seeking Manufacturer Views on Medical Device ISO Regulation
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • April 22 2016

On March 4, 2016, the FDA issued notice in the Federal Register that it had opened a docket to accept comments on the agency's proposed plan to

FDA Active on the Device Front for Q1 2016
  • Morgan Lewis & Bockius LLP
  • USA
  • April 19 2016

The US Food and Drug Administration’s (FDA’s) first quarter of calendar-year 2016 has been a busy one on the medical device front. FDA’s Center for

FTC Releases Mobile Health Apps Interactive Tool
  • McGuireWoods LLP
  • USA
  • April 12 2016

Consider this: A 42-year-old man arrives at the emergency room showing signs of a heart attack. The ER doctors, using the patient's activity

Senate HELP Committee Convenes Third and Final Cures Markup
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • April 6 2016

This morning the Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold its third and final markup for its biomedical

FDA Medical Device Safety Tracking System Reform
  • Knobbe Martens Olson & Bear LLP
  • USA
  • March 22 2016

The Los Angeles Times reports that in recent years, several devices, including certain reusable medical scopes, metal-on-metal hip replacements

Sixth Circuit Rejects FCA Claim Based on Health Data Breach
  • McDermott Will & Emery
  • USA
  • March 15 2016

On March 7, 2016, the U.S. Court of Appeals for the Sixth Circuit decided United States ex rel. Sheldon v. Kettering Health Network, affirming a

FDA Issues Draft Guidance on Medical Device Cybersecurity
  • Ropes & Gray LLP
  • USA
  • March 3 2016

On Friday, January 15, 2016, the U.S. Food and Drug Administration published the “Postmarket Management of Cybersecurity in Medical Devices Draft

Cyber attacks on smart devices: get smart
  • Kennedys Law LLP
  • European Union, USA
  • March 2 2016

We consider the potential product liability implications of cyber attacks on smart devices. In the hit film 'Kingsman: The Secret Service', a British

FDA Issues Draft Guidance Document for Postmarket Management of Cybersecurity in Medical Devices (Part 4 of 4)
  • Baker Sterchi Cowden & Rice LLC
  • USA
  • February 26 2016

The most practical portion of the FDA’s proposed guidelines is found in the Appendix. In this Section, the agency attempts to bring together all of