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Results: 1-10 of 34

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


21st Century Cures: Food and Drug Administration (FDA) Drug Provisions
  • McDermott Will & Emery
  • USA
  • January 6 2017

On December 7, 2016, the US Congress approved the 21st Century Cures Act, substantial legislation intended to accelerate "discovery, development and


21st Century Cures: Examining Medical Device Provisions
  • McDermott Will & Emery
  • USA
  • December 20 2016

The 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by


FDA Publishes Long-Awaited Draft Guidance on 510(k) Requirements for Modified Devices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On August 5, 2016, the US Food and Drug Administration (FDA) posted two long-awaited draft guidance documents intended to help industry and FDA staff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 Finalizes Guidance on Low Risk General Wellness Devices
  • McDermott Will & Emery
  • USA
  • August 3 2016

On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance


Government Issues New Tool to Help Mobile App Developers Identify Applicable Federal Laws
  • McDermott Will & Emery
  • USA
  • April 20 2016

This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the "Mobile Health Apps Interactive Tool") that is


FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness
  • McDermott Will & Emery
  • USA
  • February 17 2016

At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research


FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices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On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in


FDA releases long-awaited biological naming draft guidance and proposed rule
  • McDermott Will & Emery
  • USA
  • September 9 2015

On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the


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