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Results: 1-10 of 14

FDA Extends Unique Device Identification (UDI) System Compliance Deadlines for Certain Low-Risk Medical Devices
  • McDermott Will & Emery
  • USA
  • June 12 2017

On June 2, 2017, the US Food and Drug Administration (FDA) announced that it plans to delay the dates by which certain Class I devices and


FDA Publishes Long-Awaited Draft Guidance on 510(k) Requirements for Modified Devices
  • McDermott Will & Emery
  • USA
  • August 10 2016

On August 5, 2016, the US Food and Drug Administration (FDA) posted two long-awaited draft guidance documents intended to help industry and FDA staff


FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices
  • McDermott Will & Emery
  • USA
  • January 27 2016

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in


FDA issues draft guidance addressing reliance on ex-U.S. clinical data in medical device premarket submissions
  • McDermott Will & Emery
  • USA
  • April 29 2015

On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of


FDA will not enforce regulatory controls for medical device data systems and two other health IT devices
  • McDermott Will & Emery
  • USA
  • February 11 2015

In a move certain to please developers of health information technology (IT) products, on February 6, 2015, the U.S. Food and Drug Administration


FDA issues draft guidance on general wellness devices and on medical device accessories
  • McDermott Will & Emery
  • USA
  • February 4 2015

On January 16, 2015, the U.S. Food and Drug Administration (FDA) posted a draft guidance document outlining the FDA's proposed approach to the


FDA advises it will not enforce regulatory controls for low-risk medical information technology devices
  • McDermott Will & Emery
  • USA
  • June 25 2014

The U.S. Food and Drug Administration (FDA), in conjunction with the Office of the National Coordinator for Health Information Technology (ONC) and


FDA, ONC and FCC report outlines proposed health information technology regulatory strategy and recommendations
  • McDermott Will & Emery
  • USA
  • April 10 2014

On April 3, 2014, the U.S. Food and Drug Administration, in conjunction with the Office of the National Coordinator for Health Information Technology


FDA updates guidance addressing distribution of scientific and medical publications on unapproved new uses
  • McDermott Will & Emery
  • USA
  • March 10 2014

On February 28, 2014, the U.S. Food and Drug Administration (FDA) released a draft guidance entitled "Distributing Scientific and Medical


House passes FDA user fee bill; Congress on track to pass reconciled bill by beginning of July
  • McDermott Will & Emery
  • USA
  • June 6 2012

On May 30, 2012, the U.S. House of Representatives passed the Food and Drug Administration Reform Act of 2012the chamber’s FDA user fee authorization billby a 3875 margin