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SaMD Series: The Interplay Between IP and FDA Submissions
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • July 30 2018

Software as a Medical Device - also referred to as SaMD - is one of the fastest growing innovations in the medical device industry. As with any

Failure to Report Claimed Allowed, But Plaintiff Shouldn’t Feel Bullish
  • Dechert LLP
  • USA
  • July 24 2018

We truly dislike decisions that find that claims of failure to report adverse events to the FDA are non-preempted, parallel violation failure to warn

FDA Releases Final Guidance on Drug and Medical Product Communications with Payors and Others
  • FisherBroyles LLP
  • USA
  • June 15 2018

Earlier this week, the U.S. Food and Drug Administration (FDA) issued two new final guidance documents that provide greater clarity regarding the

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

US - APHIS to change policy for FDA approved human medical devices containing animal derived ingredients
  • Baker McKenzie
  • USA
  • May 25 2018

In a Stakeholder Importer Alert dated May 31, 2018, the Animal and Plant Health Inspection Service (APHIS), advised that in consultation with the Food

Congress Continues Push on Medical Device Cybersecurity Mandates
  • Holland & Knight LLP
  • USA
  • May 21 2018

Cybersecurity risks to the health and medical device sector continue to be front and center both in Congress and the executive branch, with increasing

FDA’s Medical Device Safety Action Plan
  • Crowell & Moring LLP
  • USA
  • May 8 2018

On April 17, 2018, the Food and Drug Administration (FDA) released its Medical Device Safety Action Plan which outlines FDA’s intended steps to

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On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and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