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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

FDA Provides Relief to Medical Device Manufacturers Under UDI
  • Arent Fox LLP
  • USA
  • November 8 2018

The FDA has delayed the date on which it plans to enforce compliance with certain Unique Device Identification (UDI) requirements, prompting a

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

Dutch Inspectorate for Health and Youth Care investigates inducement ban in medical devices sector
  • Loyens & Loeff
  • Netherlands
  • November 1 2018

The Dutch Inspectorate for Health and Youth Care (IGJ) will start an investigation regarding the inducement ban in the medical devices sector. On 1

Consider Playing By This Book's Rules: FDA-MITRE Cybersecurity Guidance
  • Baker Sterchi Cowden & Rice LLC
  • USA
  • October 31 2018

As part of Cybersecurity Awareness Month, we continue our discussion about the FDA’s efforts to help prepare various entities to address

One More Piece in the SPC Puzzle - Medical Devices with Ancillary Substances Authorised under Article 1(4) of the Medical Devices Directive Do Not Qualify for an SPC
  • Bristows
  • European Union, Germany
  • October 30 2018

On 25 October 2018 the CJEU published their latest judgment on the application of the SPC Regulation (Regulation (EC) No 4692009). The question

ECJ issues Decision on SPCs for Medical Devices
  • William Fry
  • European Union, Germany
  • October 25 2018

On 25 October 2018 the ECJ handed down decision (C-52717) responding to a preliminary ruling request from the German Federal Patents Court regarding

Product Liability in Germany
  • Hogan Lovells
  • Germany, Global
  • October 25 2018

A structured guide to product liability in Germany

FDA Announces New Efforts to Combat Cybersecurity Threats in Medical Devices
  • Morrison & Foerster LLP
  • USA
  • October 24 2018

FDA is tackling cybersecurity threats head-on and expects industry to do the same. Earlier this month, FDA commissioner Scott Gottlieb, M.D

FDA & DHS Coordinate Efforts to Address Cybersecurity
  • Knobbe Martens
  • USA
  • October 24 2018

The U.S. Food and Drug Administration (FDA) announced an agreement with the U.S. Department of Homeland Security (DHS) to strengthen the partnership