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FDA Releases New Draft Guidance Document on 3D Printing of Medical Devices
  • Hogan Lovells
  • USA
  • May 19 2016

Additive Manufacturing (AM), commonly known as 3D printing, is increasingly being used in the manufacture of medical devices, including orthopedic


FDA Clarifies Expectations for Use of Electronic Health Records in Clinical Investigations
  • Hogan Lovells
  • USA
  • May 19 2016

On May 17, 2016, FDA published a Draft Guidance for Industry regarding use of electronic health records (EHRs) in clinical trials, building on


FDA issues “leapfrog” draft guidance for 3d Printing of medical devices
  • Morgan Lewis & Bockius LLP
  • USA
  • May 19 2016

In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or Agency) issued a


The FDA seeks to regulate 3D-printed medical devices
  • Hunton & Williams LLP
  • USA
  • May 17 2016

As we previously reported, the use of 3D printing for the production of medical devices has become almost commonplace. Indeed, the FDA has approved


New FDA Guidance on Section 522 Postmarket Surveillance Studies
  • Hogan Lovells
  • USA
  • May 16 2016

Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act.1 This new guidance document provides clarifications regarding


Guest Post - Highlights of FDA Draft Guidance on 3D Printing
  • Reed Smith LLP
  • USA
  • May 12 2016

Another guest post today, this one by Reed Smith's Matt Jacobson on the draft guidance document released earlier this week by the FDA.With the 3D


FDA Issues Draft Guidance for 3D Printed Medical Devices
  • Knobbe Martens Olson & Bear LLP
  • USA
  • May 11 2016

The U.S. Food and Drug Administration (FDA) issued draft guidance for additive manufactured medical devices, more commonly known as 3D printed


FDA Publishes Draft Guidance Regarding 3D Printing Of Medical Devices
  • Reed Smith LLP
  • USA
  • May 11 2016

The U.S. Food and Drug Administration (FDA) has approved more than 80 medical devices that involve 3D printing and one prescription drug. It also held


Cybersecurity and medical devices: Electronic medical data increases product liability risk for medical device manufacturers
  • Gowling WLG
  • Canada, USA
  • May 3 2016

The value of stolen personal health information is ten to twenty times greater than a stolen credit card number.1 As the health-care industry


The writing’s on the wall: wise pharma companies will heed FDA warning in new draft guidance on data integrity cGMPs
  • DLA Piper LLP
  • USA
  • May 2 2016

FDA is again shining a spotlight on data integrity violations, announcing in a new draft Guidance for Industry: Data Integrity and Compliance with