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Results: 1-10 of 41

FDA guidances promote greater communication to payors about medical product value, clarify CFL communications
  • Hogan Lovells
  • USA
  • June 14 2018

On June 12 the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidance documents regarding the types of information that drug and


FDA proposes streamlining combination product regulations
  • Hogan Lovells
  • USA
  • May 30 2018

On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR


Parsing products: FDA regulatory policy for multi-function medical devices
  • Hogan Lovells
  • USA
  • May 4 2018

On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and


Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) pathway for certain devices
  • Hogan Lovells
  • USA
  • April 19 2018

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft


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