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Results: 1-10 of 104

Food, Drug and Device Law Alert - FDA Publishes List of Class I Devices Exempted From 510(k) Process
  • Barnes & Thornburg LLP
  • USA
  • April 13 2017

As previously reported, Congress passed and then-President Obama signed the 21st Century Cures Act last December to implement a number of FDA reforms


Food, Drug and Device Law Alert - Major FDA Reform Bill Becomes Law: Medical Device Overview
  • Barnes & Thornburg LLP
  • USA
  • December 13 2016

President Obama recently signed the 996-page 21st Century Cures Act to implement a variety of reforms to the Food and Drug Administration's (FDA


Food, Drug and Device Law Alert - FDA Issues Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food
  • Barnes & Thornburg LLP
  • USA
  • August 29 2016

As regular readers of these alerts know, almost one year ago the Food and Drug Administration (FDA) released its final rule entitled, “Current Good


Is It Juice or Sugar? Use of ‘Evaporated Cane Juice’ in Food Labels Criticized by FDA
  • Barnes & Thornburg LLP
  • USA
  • June 3 2016

The Food and Drug Administration (FDA) recently issued a final guidance for food manufacturers on the use of the term "evaporated cane juice" on food


FDA issues final rule to protect against intentional adulteration of food
  • Barnes & Thornburg LLP
  • USA
  • June 2 2016

The Food and Drug Administration (FDA) recently issued the last of the major rules implementing the Food Safety Modernization Act, titled "Focused


FDA serves up new Nutrition Facts label
  • Barnes & Thornburg LLP
  • USA
  • June 1 2016

The Food and Drug Administration (FDA) recently issued a final rule to implement the new Nutrition Facts label for packaged foods. According to the


FDA addresses postmarket surveillance for medical devices in final guidance
  • Barnes & Thornburg LLP
  • USA
  • May 31 2016

The Food and Drug Administration (FDA) recently issued a final guidance addressing postmarket surveillance for medical devices. The FDA is authorized


FDA Issues draft guidance on additive manufacturing, including 3D printing
  • Barnes & Thornburg LLP
  • USA
  • May 17 2016

The Food and Drug Administration (FDA) recently issued a draft guidance for medical device manufacturers titled "Technical Considerations for


FDA issues final rule on sanitary transportation of food
  • Barnes & Thornburg LLP
  • USA
  • April 7 2016

Food and Drug Administration (FDA) recently issued the sixth of the seven major final rules required by the Food Safety Modernization Act (FSMA), one


FDA issues draft guidance on cybersecurity for medical devices
  • Barnes & Thornburg LLP
  • USA
  • January 19 2016

The Food and Drug Administration (FDA) recently issued a draft guidance, “Postmarket Management of Cybersecurity in Medical Devices,” addressing