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On October 14, 2016, FDA released draft guidance entitled Software as a Medical Device (SaMD): Clinical Evaluation (the “SaMD Draft Guidance”).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

Heart device warning following death of two people in US
  • Leigh Day
  • United Kingdom, USA
  • October 13 2016

The FDA has issued a warning following two deaths in the US connected to premature battery depletion in St Jude Medical Cardiac implantable

10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications
  • Morgan Lewis & Bockius LLP
  • USA
  • October 4 2016

The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation

Comments Due November 1, 2016 on Proposed Update to Framework for Biotechnology Regulation
  • Beveridge & Diamond PC
  • USA
  • September 23 2016

On September 18, 2016, the Obama Administration issued two major documents in connection with its ongoing efforts to modernize the federal

“World’s Smallest Pacemaker” Experiences Sizeable Success
  • Knobbe Martens Olson & Bear LLP
  • USA
  • September 6 2016

Medtronic recently announced continued success with what it describes as “the world’s smallest pacemaker.” The Micra Transcatheter Pacing System

FDA proposes important revisions to good laboratory practices regulations
  • Arnold & Porter LLP
  • August 30 2016

On August 24, 2016, the Food and Drug Administration (FDA) published a proposed rule which would amend the decades-old regulations governing good

FDA Releases Revised Guidance on Device Modification Policy
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • August 16 2016

FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the

FDA and OHRP Issue Joint Draft Guidance on IRB Written Procedures
  • McDermott Will & Emery
  • USA
  • August 15 2016

On August 2, 2016, the US Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) jointly issued draft guidance

Food, Drug and Device Law - FDA Finalizes Guidance on General Wellness Devices, Will Not Regulate
  • Barnes & Thornburg LLP
  • USA
  • August 12 2016

The FDA recently issued a final guidance titled "General Wellness: Policy for Low Risk Devices." The guidance sets forth FDA's compliance policy for