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Results: 1-10 of 1,578

U.S. House of Representatives Passes 21st Century Cures Act, Including Numerous Device-Related Provisions
  • Hogan Lovells
  • USA
  • December 7 2016

Last Wednesday evening (November 30), the House overwhelmingly passed (by a vote of 392-26) a compromise version of the 21st Century Cures Act. House


FDA Issues Draft Guidance for Clinical Evaluation of Software As A Medical Device
  • Arnold & Porter LLP
  • USA
  • November 22 2016

Last month, the US Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) issued a Draft Guidance for Industry


Consumer Protection in Retail: Weekly Roundup
  • Hunton & Williams LLP
  • USA
  • November 22 2016

The Eleventh Circuit Court of Appeals stayed an FTC Final Order requiring the now-defunct LabMD to implement numerous compliance measures stemming


FDA Releases Final Guidance on Medical Device Reporting for Manufacturers
  • Arnold & Porter LLP
  • USA
  • November 18 2016

On Nov. 8, the FDA finalized its 2013 draft guidance on the Medical Device Reporting (MDR) regulation. The guidance supersedes the FDA's previous


Software as a Medical Device: FDA Releases Draft Guidance
  • Pepper Hamilton LLP
  • USA
  • November 9 2016

Companies that develop software that functions as a medical device should be aware that the Food and Drug Administration (FDA) has issued draft


The Latest on Drug Master Files for Packaging Materials in the United Statesand a Little History
  • Keller and Heckman LLP
  • USA
  • November 1 2016

The U.S. FDA evaluates the safety and suitability of drug packaging as part of the premarket approval process for new drugs. The manner in which


New FDA Reporting Tool Encourages Whistleblowers
  • Hogan Lovells
  • USA
  • October 28 2016

On Tuesday, October 25, 2016, the U.S. Food and Drug Administration (FDA or the agency) announced a new online tool and accompanying guidance for


Clinical Evaluation of Medical Software: FDA Proposes International Guidance
  • Hogan Lovells
  • USA
  • October 24 2016

On October 14, 2016, the Food and Drug Administration (FDA or the Agency) released a draft guidance document addressing clinical evaluation for


3D Printing Quarterly Report - Q3
  • Benesch Friedlander Coplan & Aronoff LLP
  • USA
  • October 20 2016

This report explores recent developments across 12 sectors as it relates to 3D printing and its impact on each sector. We've limited our scan to the


FDA Opens Comment Period for Harmonized SaMD Clinical Evaluation Guidance
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • October 17 2016

On October 14, 2016, FDA released draft guidance entitled Software as a Medical Device (SaMD): Clinical Evaluation (the “SaMD Draft Guidance”). The