We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 53

Paving the way for product authorization: FDA proposes rule to reclassify medical image analyzers
  • Hogan Lovells
  • USA
  • June 15 2018

On June 4, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed order to reclassify certain software that analyzes


Internet of Things Webinar Recording: Medical Devices
  • Hogan Lovells
  • USA
  • June 14 2018

In the third instalment of the 2018 Internet of Things Webinar (IoT) Series, Yarmela Pavlovic, Paul Otto, Elisabethann Wright, and Fabien Roy hosted


Parsing products: FDA regulatory policy for multi-function medical devices
  • Hogan Lovells
  • USA
  • May 4 2018

On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and


FDA releases working model for Software Precertification Pilot Program
  • Hogan Lovells
  • USA
  • May 3 2018

Last week, the U.S. Food and Drug Administration (FDA or the Agency) released updates to its Software Precertification (Pre-Cert) Pilot Program


FDA signals increasing focus on cybersecurity requirements
  • Hogan Lovells
  • USA
  • April 25 2018

With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial


FDA finalizes guidances for NGS-based tests
  • Hogan Lovells
  • USA
  • April 20 2018

On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing


Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) pathway for certain devices
  • Hogan Lovells
  • USA
  • April 19 2018

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft


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