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FDA Issues New Draft Guidance on “Least Burdensome” Principles for Medical Devices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December 15, the U.S. Food & Drug Administration (FDA) issued “The Least Burdensome Provisions: Concept and Principles: Draft Guidance for Industry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 cybersecurity for medical devices
  • Drinker Biddle & Reath LLP
  • USA
  • November 24 2014

On October 2, the FDA issued guidance on cybersecurity for medical devices containing software in order "to assist industry by identifying issues


FDA releases FDASIA Health IT Report
  • Drinker Biddle & Reath LLP
  • USA
  • April 18 2014

On April 3, 2014, the Food and Drug Administration (FDA) released the FDASIA Health IT Report (Report). This Report fulfills Section 618 of the Food


The debate over mobile health software regulation
  • Drinker Biddle & Reath LLP
  • USA
  • December 4 2013

On November 19th, the House Energy and Commerce Subcommittee on Health held a hearing to examine the federal regulation of mobile medical


23 skidoo genomes, gamesmanship and the First Amendment
  • Drinker Biddle & Reath LLP
  • USA
  • November 26 2013

On November 22, 2013, the Inquisition collided with the Internet. On that date, the Food and Drug Administration issued a Warning Letter threatening


FDA’s warning letter to 23andMe: ethical and legal issues
  • Drinker Biddle & Reath LLP
  • USA
  • November 26 2013

The FDA's warning letter to 23andMe, the maker of mail-order genetic tests, highlights the challenging legal and ethical issues posed by such


FDA final guidance on mobile medical applications
  • Drinker Biddle & Reath LLP
  • USA
  • November 22 2013

On September 23, 2013, the FDA issued a guidance ("Final Guidance") explaining how medical device regulations will be applied to medical mobile


Overhaul of FCC experimental licensing rules
  • Drinker Biddle & Reath LLP
  • USA
  • May 29 2013

In an attempt to bring clarity to its current experimental licensing rules and policies, and to expand the opportunities for manufacturers and


Privately held medical device and drug companies face unique Sunshine Act challenges
  • Drinker Biddle & Reath LLP
  • USA
  • May 17 2013

As widely reported, the Centers for Medicare and Medicaid Services ("CMS") recently issued regulations implementing the Sunshine Act provisions of


The perils and promise of 3D printing: are DIY life sciences in your future?
  • Drinker Biddle & Reath LLP
  • USA
  • May 13 2013

With news that 3D printing (without question one of the coolest technologies to come down the road in quite some time) can be used to produce guns