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Results: 1-10 of 37

FDA proposes rule to codify existing guidance on supervisory review of CDRH decisions
  • Hogan Lovells
  • USA
  • January 31 2018

On January 17, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule to update the framework for requesting internal


FDA finalizes 3D printing guidance
  • Hogan Lovells
  • USA
  • December 20 2017

On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its "leapfrog guidance" entitled, "Technical


Clarifying Digital Health and Software Regulation: FDA Releases Three New Guidance Documents
  • Hogan Lovells
  • USA
  • December 15 2017

On December 7, 2017, the Food and Drug Administration (FDA or the Agency) released three guidance documents that together aim to clarify the framework


FDA issues long-awaited final guidance on when a device modification requires a new 510(k)
  • Hogan Lovells
  • USA
  • November 2 2017

Six years after its first attempt to update its now 20-year-old guidelines for when modifications to a 510(k)-cleared device require the submission


Working together: FDA releases final guidance on interoperability
  • Hogan Lovells
  • USA
  • October 3 2017

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market


House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech
  • Hogan Lovells
  • USA
  • July 8 2017

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017


Gottlieb Announces New Regulatory Paradigm for Digital Health Software
  • Hogan Lovells
  • USA
  • June 19 2017

The development of medical software products presents the opportunity to notably improve a number of healthcare issues in the U.S. today, such as


FDA: Implementation of Amended Intended Use Regulations Delayed Until March 21, 2017
  • Hogan Lovells
  • USA
  • February 8 2017

On February 7, 2017, the Food and Drug Administration (FDA) delayed implementation of its January 9, 2017, final rule addressing the regulation of


FDA Clarifies “Intended Use” Regulations: Knowledge Alone Intent, But Knowledge Certainly Can Be One Element in Establishing the Totality of the Evidence
  • Hogan Lovells
  • USA
  • January 19 2017

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug


On the Heels of 21st Century Cures Enactment, FDA Finalizes Medical Device Accessories Guidance
  • Hogan Lovells
  • USA
  • January 4 2017

On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories -