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FDA Delays eMDR System Adverse Event Codes Update
  • Morgan Lewis
  • USA
  • March 30 2018

The electronic medical device reporting system adverse event code update was originally planned for deployment in April, but was delayed until July 5


What Pharma Companies Need to Know about FDA’s New Draft IVD Guidance
  • Morgan Lewis
  • USA
  • January 24 2018

As precision medicine gains momentum and in vitro diagnostics (IVDs) become increasingly used in clinical trials, pharma and biotech companies will


FDA Announces Digital Health Innovation Action Plan to Implement 21st Century Cures Act
  • Morgan Lewis
  • USA
  • August 14 2017

LawFlash Agency also launches voluntary pilot program as first step in developing software pre-certification program. On July 27, the US Food and Drug


Congressional Committees Propose Restructuring of User Fees in Draft Language
  • Morgan Lewis
  • USA
  • April 21 2017

On April 14, the health committees for both the US Senate and the US House of Representatives released a discussion draft of legislation to


New York Attorney General Settles Claims against Three Health Apps
  • Morgan Lewis
  • USA
  • April 12 2017

On March 23, New York Attorney General Eric T. Schneiderman announced a settlement with developers of three health-related applications (health


FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months
  • Morgan Lewis
  • USA
  • February 13 2017

Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration's (FDA's or the Agency's) Center for


FDA Issues Final Guidance on Postmarket Cybersecurity
  • Morgan Lewis
  • USA
  • January 10 2017

On December 28, 2016, FDA issued a final guidance titled "Postmarket Management of Cybersecurity in Medical Devices" (Final Guidance). A draft


FDA Issues Final Guidance on “Emerging Signals”
  • Morgan Lewis
  • USA
  • December 21 2016

On December 14, 2015, the FDA issued a final guidance titled "Public Notification of Emerging Postmarket Medical Device Signals" (Final Guidance


21st Century Cures Act and Medical Device Regulatory Pathways
  • Morgan Lewis
  • USA
  • December 9 2016

The US Senate passed the 21st Century Cures Act on December 7, and President Barack Obama is expected to sign the bill into law. Included in the


21st Century Cures Act and Its Effect on Digital Health
  • Morgan Lewis
  • USA
  • December 8 2016

On December 7, the US Senate passed the 21st Century Cures Act and sent it to President Barack Obama, who has promised to sign it. This new