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Results:1-10 of 11

FDA extends risk-based medical app approach to Medical Device Data Systems in new guidance
  • Kelley Drye & Warren LLP
  • USA
  • February 17 2015

The recent release of two guidance documents addressing current FDA enforcement policies for medical devices that are Medical Device Data Systems


FDA holds October workshop to catalyze collaborative approach to healthcare and medical device cybersecurity; seeks comment from interested parties
  • Kelley Drye & Warren LLP
  • USA
  • October 30 2014

On October 21-22, 2014, the Food and Drug Administration (FDA) hosted a public workshop on health-related cybersecurity issues. The workshop was


FDA seeks to catalyze collaborative approaches for medical device and healthcare cybersecurity; announces October workshop and comment deadlines
  • Kelley Drye & Warren LLP
  • USA
  • September 29 2014

On September 23, 2014, the Food and Drug Administration (FDA) released a notice of public workshop and Request for Comments on health-related


Day 2 of medical device mobile app hearings focuses on patient benefits
  • Kelley Drye & Warren LLP
  • USA
  • March 22 2013

The Health Subcommittee of the House of Representatives Energy and Commerce Committee held a second day of hearings regarding medical device mobile


DHHS and FDA officials respond to medical device mobile application regulatory concerns on final day of hearings
  • Kelley Drye & Warren LLP
  • USA
  • March 22 2013

The House Subcommittee on Oversight and Investigations concluded a three-day series of hearings regarding medical device mobile applications ("MMAs")


House subcommittee holds Day 1 of hearings on medical device mobile apps
  • Kelley Drye & Warren LLP
  • USA
  • March 20 2013

The Communications and Technology subcommittee of the House of Representatives Energy and Commerce Committee held its first day of a three-day series


House Energy and Commerce Committee to hold hearings on regulation of medical device mobile applications
  • Kelley Drye & Warren LLP
  • USA
  • March 14 2013

The House of Representatives Committee on Energy and Commerce (the "Committee") is set to hold a three-day series of hearings next week regarding


There’s an app for that: FDA clears iPhone iExaminer app
  • Kelley Drye & Warren LLP
  • USA
  • January 29 2013

FDA recently granted clearance to a new telemedicine product - the Welch Allyn iExaminer - which, when used in conjunction with the iPhone, allows


FDA proposed rule would place new labeling and reporting requirements on medical device manufacturers
  • Kelley Drye & Warren LLP
  • USA
  • July 24 2012

On July 10, 2012, the Food and Drug Administration (“FDA”) published a proposed rule implementing Federal Food, Drug, and Cosmetic Act (“FD&C Act”) provisions establishing a unique device identification system for medical devices over the next seven years.


FDA proposes rule mandating unique device identifiers for medical devices
  • Kelley Drye & Warren LLP
  • USA
  • July 23 2012

On July 10, 2012, the Food and Drug Administration published a proposed rule implementing Federal Food, Drug, and Cosmetic Act provisions establishing a unique device identification system for medical devices.