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FDA Issues Draft Guidance on Expanding Special 510(k) Program
  • Barnes & Thornburg LLP
  • USA
  • October 11 2018

The FDA recently released a draft guidance titled “The Special 510(k) Program.” According to the draft guidance, its purpose is to describe an


FDA Issues Final Guidance on Medical Device Benefit and Risk Analysis for 510(k)s
  • Barnes & Thornburg LLP
  • USA
  • October 5 2018

The FDA recently released a final guidance titled “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket


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FDA Draft Guidance Revamps Assessment of Multiple Function Devices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The FDA recently issued a draft guidance titled, "Multiple Function Device Products: Policy and Considerations," which seeks to clarify FDA's policy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The Food and Drug Administration (FDA) recently issued a draft guidance titled “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial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 - 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