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FDA Extends Unique Device Identification (UDI) System Compliance Deadlines for Certain Low-Risk Medical Devices
  • McDermott Will & Emery
  • USA
  • June 12 2017

On June 2, 2017, the US Food and Drug Administration (FDA) announced that it plans to delay the dates by which certain Class I devices and

FDA Extends the UDI Compliance Date for Certain Class I and Unclassified Devices
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • June 8 2017

With the deadline for compliance with the unique device identification systemi (UDI system) requirements for certain Cass I and unclassified devices

FDA Begins Reorganization that Will Affect How it Regulates Medical Technology
  • Hogan Lovells
  • USA
  • June 1 2017

The U.S. Food and Drug Administration (FDA) has undertaken significant reorganization efforts this year that affect the way it regulates medical

Brave New World: Compliance and the Transition to Value-Based Care
  • Ropes & Gray LLP
  • USA
  • May 22 2017

The U.S. health care system is in the midst of a fundamental shift, away from traditional “fee-for-service” models that reward providers for the

Medical Device Regulation Update
  • K&L Gates
  • European Union
  • May 9 2017

On 5 May 2017, the Medical Device Regulation ("MDR") was published in the Official Journal of the European Union and comes into effect on 26 May 2017

HFN Technology & Regulation Client Update
  • Herzog Fox & Neeman
  • Israel
  • February 27 2017

The beginning of 2017 has been marked by a variety of regulatory and compliance developments in technology compliance, digital advertising, big data

OIG 2017 Work Plan Lists New Enforcement Priorities
  • Arent Fox LLP
  • USA
  • November 29 2016

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published its Work Plan for Fiscal Year 2017 (2017 Work

New UK Code of Practice for Medical Devices and Medical Technology
  • Arnold & Porter Kaye Scholer LLP
  • United Kingdom, European Union
  • November 2 2016

On October 2016, the Association of British Healthcare Industries (ABHI), with over 250 company members, published significant changes to its Code of

Healthcare Business Associates
  • Bryan Cave Leighton Paisner (Bryan Cave)
  • USA
  • September 28 2016

The Health Information Technology for Economic and Clinical Health (“HITECH”) Act modified the Health Insurance Portability and Accountability Act

FDA Uses Summer to Issue Numerous Device Guidance Documents
  • Morgan Lewis
  • USA
  • August 31 2016

Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active