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FDA Issues First Installment of Guidance on ‘Mitigation Strategies to Protect Food Against Intentional Adulteration’ Rule
  • Barnes & Thornburg LLP
  • USA
  • July 3 2018

As part of its implementation of the Food Safety Modernization Act, the FDA two years ago published a final rule titled, “Mitigation Strategies to


FDA Draft Guidance Revamps Assessment of Multiple Function Devices
  • Barnes & Thornburg LLP
  • USA
  • May 8 2018

The FDA recently issued a draft guidance titled, "Multiple Function Device Products: Policy and Considerations," which seeks to clarify FDA's policy


FDA to Expand Abbreviated 510(k) Pathway for Medical Devices by Allowing Comparison to Performance Criteria
  • Barnes & Thornburg LLP
  • USA
  • April 20 2018

The Food and Drug Administration (FDA) recently issued a draft guidance titled “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial


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Food, Drug and Device Law Alert - FDA Issues Draft Guidance on Convening Panels to Review Food Safety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The Food and Drug Administration (FDA) recently issued a draft guidance titled "Best Practices for Convening GRAS Panels: Guidance for Industry."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