We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results:1-10 of 10

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FDA Publishes Long-Awaited Draft Guidance on 510(k) Requirements for Modified Devices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On August 5, 2016, the US Food and Drug Administration (FDA) posted two long-awaited draft guidance documents intended to help industry and FDA staff


FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices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On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in


FDA issues draft guidance addressing reliance on ex-U.S. clinical data in medical device premarket submissions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On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of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FDA issues draft guidance on general wellness devices and on medical device accessories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On January 16, 2015, the U.S. Food and Drug Administration (FDA) posted a draft guidance document outlining the FDA's proposed approach to the


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.


Senate easily passes FDA user fee bill, reconciliation with House version looms
  • McDermott Will & Emery
  • USA
  • May 29 2012

In a nearly unanimous decision, the U.S. Senate passed the Food and Drug Administration Safety and Innovation Act on May 24, 2012.


FDA finalizes benefit-risk determination methodology for certain medical devices
  • McDermott Will & Emery
  • USA
  • April 18 2012

In an attempt to improve the predictability, consistency and transparency of the medical device review process, the U.S. Food and Drug Administration recently released final guidance describing the principal factors the agency will consider when making benefit-risk determinations during the premarket approval and de novo classification processes, respectively.