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Food, Drug and Device Law Alert - FDA Issues Amended Final Guidance on Medical Device Accessories
  • Barnes & Thornburg LLP
  • USA
  • January 2 2018

The Food and Drug Administration (FDA) issued several medical device guidance documents late last year, including an amended version of a previously


Food, Drug and Device Law Alert - FDA Issues Draft Guidance on Convening Panels to Review Food Safety
  • Barnes & Thornburg LLP
  • USA
  • November 21 2017

The Food and Drug Administration (FDA) recently issued a draft guidance titled "Best Practices for Convening GRAS Panels: Guidance for Industry." All


Food, Drug and Device Law Alert - FDA’s Final Guidance Restricts Sharing Patient-Specific Information
  • Barnes & Thornburg LLP
  • USA
  • November 3 2017

The Food and Drug Administration (FDA) recently issued a brief final guidance titled "Manufacturers Sharing Patient-Specific Information from Medical


Food, Drug and Device Law Alert - FDA Updates De Novo Medical Device Classification Process
  • Barnes & Thornburg LLP
  • USA
  • November 1 2017

The Food and Drug Administration (FDA) recently issued a final guidance titled “De Novo Classification Process (Evaluation of Automatic Class III


Food, Drug and Device Law Alert - FDA Reauthorization Act Requires Changes to Medical Device Inspections
  • Barnes & Thornburg LLP
  • USA
  • September 18 2017

Last month, President Trump signed the FDA Reauthorization Act of 2017 (FDARA), which included user fee provisions to partially fund FDA's operations


Food, Drug and Device Law Alert - FDA to Hold Public Meeting to Discuss Developing a List of Pre-DSHEA Dietary Ingredients
  • Barnes & Thornburg LLP
  • USA
  • September 12 2017

The U.S. Food and Drug Administration (FDA) will hold a public meeting to discuss its efforts to develop a list of dietary ingredients that pre-date


Food, Drug and Device Law Alert - FDA Issues Guidance on Qualification of Medical Device Development Tools
  • Barnes & Thornburg LLP
  • USA
  • August 23 2017

The U.S. Food and Drug Administration (FDA) recently issued a final guidance titled "Qualification of Medical Device Development Tools." According to


FDA Publishes Q&A on Precertification Pilot Program for Software Developers
  • Barnes & Thornburg LLP
  • USA
  • August 18 2017

On September 1, the Food and Drug Administration (FDA) will launch a precertification pilot program for software developers, but has limited the


Food, Drug and Device Law Alert - FDA Publishes List of Class II Devices to Be Exempted From 510(k) Process
  • Barnes & Thornburg LLP
  • USA
  • July 24 2017

The 21st Century Cures Act required the Food and Drug Administration (FDA) to publish a notice in the Federal Register - within 120 days for Class I


Post-BMS, Are Clinical-Trial Sites the New Hook for Hailing Out-of-State Pharmaceutical Defendants into Court?
  • Barnes & Thornburg LLP
  • USA
  • July 13 2017

The ink has only recently dried on the U.S. Supreme Court's June 19 personal jurisdiction decision in Bristol-Meyers Squibb Co. v. Superior Court of