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FDA Approval of 23andMe Genomic Test Shows the Way for Direct-to-Consumer Diagnostics
  • Knobbe Martens Olson & Bear LLP
  • USA
  • April 19 2017

On April 6, 2017 the FDA Center for Devices and Radiological Health formally approved 23andMe’s Personal Genome Services Test as a Class II Medical


Update on Contamination of Heater-Cooler Devices
  • Stark & Stark
  • USA
  • April 18 2017

The Food and Drug Administration (FDA) recently issued a Medical Device Safety Communication update to provide new information about Mycobacterium


April 2017 International Trade Compliance Update
  • Baker McKenzie
  • Canada, European Union, United Kingdom, USA
  • April 12 2017

The WTO announced that WTO members discussed five new or enhanced proposals to advance services negotiations at meetings of the Working Party on


Mobile Health App Makers Investigated for Fraud Enter into Settlement With the Office of the Attorney General for the State of New York
  • Pietragallo Gordon Alfano Bosick & Raspanti LLP
  • USA
  • March 28 2017

New York State Attorney General, A.G. Schneiderman, has put mobile health application developers on notice - “We won’t tolerate non-evidence-based


Clinical trials in the USA
  • Perkins Coie LLP
  • Global, USA
  • February 24 2017

A structured guide to clinical trials in the USA


Final Guidance Sheds Light on Medical Device Reporting Requirements
  • Haynes and Boone LLP
  • USA
  • February 15 2017

In November 2016, the U.S. Food and Drug Administration ("FDA") issued a final guidance on medical device reporting for manufacturers ("Final MDR


St. Jude Cybersecurity Vulnerability Extended to Provider-Owned Devices
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • February 9 2017

Earlier this week, the U.S. Department of Homeland Security (DHS) updated a prior advisory revealing cybersecurity vulnerabilities in St. Jude


Trump’s 2-for-1 Executive Order and its Impact on FDA
  • Arent Fox LLP
  • USA
  • February 3 2017

On the heels of a January 20, 2017 memorandum freezing the release of any new or pending regulations until they have been reviewed and approved by


False Claims Act: 2016 Year-in-Review
  • Wilmer Cutler Pickering Hale and Dorr LLP
  • USA
  • February 1 2017

In 2016, the Department of Justice (DOJ) continued to give high priority to False Claims Act (FCA) investigations and prosecutions. The government


FTC Cries Foul On Breathometer Accuracy Claims
  • Kelley Drye & Warren LLP
  • USA
  • February 1 2017

The FTC recently announced a settlement with Breathometer, Inc., a company that marketed a smartphone accessory that it claimed could detect blood