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Results: 1-10 of 46

Obtaining FDA clearance or approval of digital health products
  • Hogan Lovells
  • USA
  • March 14 2018

Many digital health products are regulated by the U.S. Food and Drug Administration (FDA) as medical devices or, when used in conjunction with a


FDA finalizes 3D printing guidance
  • Hogan Lovells
  • USA
  • December 20 2017

On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its "leapfrog guidance" entitled, "Technical


Clarifying Digital Health and Software Regulation: FDA Releases Three New Guidance Documents
  • Hogan Lovells
  • USA
  • December 15 2017

On December 7, 2017, the Food and Drug Administration (FDA or the Agency) released three guidance documents that together aim to clarify the framework


FDA issues long-awaited final guidance on when a device modification requires a new 510(k)
  • Hogan Lovells
  • USA
  • November 2 2017

Six years after its first attempt to update its now 20-year-old guidelines for when modifications to a 510(k)-cleared device require the submission


FDA Finalizes Guidance on Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies
  • Hogan Lovells
  • USA
  • October 4 2017

On September 12, 2017, the U.S. Food and Drug Administration (FDA) released the final guidance that outlines the agency’s expectations and


Working together: FDA releases final guidance on interoperability
  • Hogan Lovells
  • USA
  • October 3 2017

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market


New FDA Final Guidance on Medical Device Panel Meetings Provides Certain Changes to Timelines and Procedures
  • Hogan Lovells
  • United Kingdom
  • September 20 2017

On September 1, 2017, the Food and Drug Administration (FDA or the Agency) released a final guidance document discussing the procedures for Medical


FDA's Software Pre-Cert Program: More Details Revealed
  • Hogan Lovells
  • USA
  • August 9 2017

In follow up to the U.S. Food and Drug Administration's (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot


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


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