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Results:1-10 of 307

FDA De Novo Device Classification Process & Preemption
  • Reed Smith LLP
  • USA
  • December 10 2018

The FDA has recently released a proposed rule “to establish requirements for the medical device De Novo classification process” provided in 21 U.S.C


FDA Announces Its Plan for Encouraging Reliance on Newer Predicate Devices and Medical Device Performance Criteria
  • Reed Smith LLP
  • USA
  • December 7 2018

On November 26, 2018, the Food & Drug Administration (FDA) announced its intent “to modernize the FDA’s 510(k) clearance pathway” by encouraging


“Alter Ego” Allegations Aren’t Enough For Personal Jurisdiction
  • Reed Smith LLP
  • USA
  • December 7 2018

A federal court in Utah ruled the other day that it had no personal jurisdiction over a corporate parent, even though the plaintiffs alleged that the


A Couple of MDL Ideas from the Recent ACI DrugDevice Conference
  • Reed Smith LLP
  • USA
  • December 6 2018

Late last month Bexis attended the annual ACI Drug and Medical Device Conference in New York. In between helping to lead the discussion in the


Personal Jurisdiction Wins Cases
  • Reed Smith LLP
  • USA
  • November 29 2018

We’ve discussed personal jurisdiction a lot on the Blog lately, and not so lately, and for good reason. The Supreme Court’s reining in of both general


Biomaterials Access for the 21st Century
  • Reed Smith LLP
  • USA
  • November 12 2018

We’ve blogged several times about the Biomaterials Access Assurance Act of 1998, 21 U.S.C. 1601-06. In a nutshell, the BAAA provides suppliers of


D. Colorado Applies Learned Intermediary Rule to Medical Devices
  • Reed Smith LLP
  • USA
  • November 7 2018

A federal judge in one of our non-drug or device cases recently informed the parties that he was so busy with his criminal docket that it might be


FDA Continues Its Press On Medical Device Cybersecurity
  • Reed Smith LLP
  • USA
  • October 12 2018

Did you know that October is National Cybersecurity Awareness Month? Neither did we, until we started poking around the FDA’s recent press release


Life Sciences: product regulation and liability in France
  • Reed Smith LLP
  • France, Global
  • October 4 2018

A structured guide to product regulation and liability laws in France


Sameness: Not Desirable in Society; Not Attainable in Medical Device Class Action
  • Reed Smith LLP
  • USA
  • May 8 2018

This DDL blogger happens to have a relatively new teenager in the house. And said teen has been working on an assignment related to the novel by Lois