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FDA Announces Digital Health Innovation Action Plan to Implement 21st Century Cures Act
  • Morgan Lewis & Bockius LLP
  • 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 & Bockius LLP
  • 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 & Bockius LLP
  • 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 & Bockius LLP
  • 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 & Bockius LLP
  • 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 & Bockius LLP
  • 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 & Bockius LLP
  • 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 & Bockius LLP
  • 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


Top Takeaways from FDA Draft Guidance on Software as a Medical Device
  • Morgan Lewis & Bockius LLP
  • USA
  • November 14 2016

On October 14, the US Food and Drug Administration (FDA or the Agency) releaseda new draft guidance document, Software as a Medical Device (SaMD):


FDA Uses Summer to Issue Numerous Device Guidance Documents
  • Morgan Lewis & Bockius LLP
  • USA
  • August 31 2016

Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active