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Food, Drug and Device Law Alert - FDA Makes Revisions to Two Medical Device Application Process Documents
  • Barnes & Thornburg LLP
  • USA
  • February 5 2018

The FDA recently issued two revised final medical device guidance documents titled, “Refuse to Accept Policy for 510(k)s” and“Acceptance and Filing


Food, Drug and Device Law Alert - New Guidance Details FDA’s Intent to Use Discretion for Enforcing Portions of Food Safety Modernization Act
  • Barnes & Thornburg LLP
  • USA
  • January 23 2018

Earlier this month, the Food and Drug Administration (FDA) issued a guidance, "Policy Regarding Certain Entities Subject to the Current Good


Food, Drug and Device Law Alert - FDA Proposes Defining ‘Significant Decision’ in Safety and Innovation Act
  • Barnes & Thornburg LLP
  • USA
  • January 23 2018

The Food and Drug Administration (FDA) recently issued a proposed rule that would define terms in Section 603 of the FDA Safety and Innovation Act


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Food, Drug and Device Law Alert - FDA Issues Draft Guidance on Convening Panels to Review Food Safety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The Food and Drug Administration (FDA) recently issued a draft guidance titled "Best Practices for Convening GRAS Panels: Guidance for Industry."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