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Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns
  • Hogan Lovells
  • USA
  • January 17 2018

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations

FDA Releases 2018 Roadmap: Focus On Digital Health Continues
  • Kelley Drye & Warren LLP
  • USA
  • January 16 2018

Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic

3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing
  • Morrison & Foerster LLP
  • USA
  • January 16 2018

In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The

The Crackdown Continues: FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety Concerns
  • Hogan Lovells
  • USA
  • January 5 2018

Yesterday, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcellan adipose tissue derived stem cell

FDA Guidance on Decision Support Software: Implications for Industry
  • Epstein Becker Green
  • USA
  • January 3 2018

On December 8, 2017, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Clinical and Patient Decision Support Software”

Food, Drug and Device Law Alert - FDA Issues Amended Final Guidance on Medical Device Accessories
  • Barnes & Thornburg LLP
  • USA
  • January 2 2018

The Food and Drug Administration (FDA) issued several medical device guidance documents late last year, including an amended version of a previously

US FDA Issues New Guidance for Digital Health
  • Baker McKenzie
  • USA
  • December 26 2017

With the increasing prevalence of digital health products and technology, the US Food and Drug Administration (US FDA) has launched several new pieces

The Latest FDA Move To Limit Digital Health Software Regs
  • Ropes & Gray LLP
  • USA
  • December 22 2017

On Dec. 8, 2017, the U.S. Food and Drug Administration issued two draft guidance documents that describe types of software functions that the FDA

FDA Issues New Draft Guidance on “Least Burdensome” Principles for Medical Devices
  • Drinker Biddle & Reath LLP
  • USA
  • December 21 2017

On December 15, the U.S. Food & Drug Administration (FDA) issued “The Least Burdensome Provisions: Concept and Principles: Draft Guidance for Industry

FDA Issues Guidance on Clinical and Patient Decision Support Software
  • Squire Patton Boggs
  • USA
  • December 20 2017

On December 8, 2017, the Food and Drug Administration (FDA) published a notice of availability for the Clinical and Patient Decision Support Software