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Embrace Neonatal MRI Device Gains FDA Clearance
  • Knobbe Martens
  • USA
  • August 10 2017

On July 20, 2017, the Food and Drug Administration announced the clearance of "the first magnetic resonance imaging (MRI) device specifically for


New Proposed US Legislation Focuses on Medical Device Cybersecurity
  • Baker McKenzie
  • USA
  • August 9 2017

Senator Richard Blumenthal (D-CT) introduced a bill (S.1656), The Medical Device Cybersecurity Act of 2017 (Bill), on July 27, 2017. The Bill aims to


A Modern Approach To Digital Health Product Regulation
  • Ropes & Gray LLP
  • USA
  • August 7 2017

As part of an overarching initiative to update its regulatory oversight of digital health technologies, the U.S. Food and Drug Administration has


New FDA Digital Health Program
  • Holland & Knight LLP
  • USA
  • August 1 2017

The Food and Drug Administration (FDA) continues to flesh out its ideas for regulation of digital health. Last week, the agency published a notice in


Food & Beverage Litigation Update - Issue 642
  • Shook Hardy & Bacon LLP
  • European Union, USA
  • July 28 2017

European Commission President Jean-Claude Juncker has reportedly indicated the EU will issue guidelines discouraging


Follow the Money: FDA Issues New Procedures for Evaluating Financial Ties Between Application Sponsors and Clinical Investigators
  • Hogan Lovells
  • USA
  • July 5 2017

In a potential sign of renewed interest in financial ties between industry and clinical investigators, the Food and Drug Administration’s (FDA


Electric boogaloo: FDA releases sequel to 2003 guidance on use of electronic records and electronic signatures in clinical investigations
  • Hogan Lovells
  • USA
  • June 27 2017

Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11 Questions and Answers." The draft guidance is intended


FDA Requires Reprocessing Validation Data for Certain Reusable Devices
  • Hogan Lovells
  • USA
  • June 20 2017

On June 9, 2017, the U.S. Food and Drug Administration (“FDA”) published a Federal Register Notice announcing that new 510(k) notices for a number of


Gottlieb Announces New Regulatory Paradigm for Digital Health Software
  • Hogan Lovells
  • USA
  • June 19 2017

The development of medical software products presents the opportunity to notably improve a number of healthcare issues in the U.S. today, such as


FDA to Create New Digital Health Unit
  • Knobbe Martens
  • USA
  • June 16 2017

The FDA has announced that it will create a new unit responsible for overseeing digital health products. According to Bakul Patel, the Associate