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FDA seeks enhanced cybersecurity risk management efforts, including premarket submission requirements, for medical device manufacturers and hospitals

  • Hogan Lovells
  • -
  • USA
  • -
  • June 19 2013

Drawing on the increasing use of wireless, Internet- and network-connected medical devices, the Food and Drug Administration ("FDA" or "the Agency"

Federal Court rules against HHS in FOIA litigation over Formaldehyde Carcinogen listing

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • February 28 2013

A federal court in the District of Columbia has ruled that the Department of Health and Human Services (HHS) did not "demonstrate beyond material

Congressional health policy hearings & markups

  • Reed Smith LLP
  • -
  • USA
  • -
  • November 11 2011

A number of Congressional committees have held hearings recently on health policy issues

Your software may be a ‘medical device’ subject to FDA regulation

  • Fish & Richardson PC
  • -
  • USA
  • -
  • August 10 2011

In late July 2011, the FDA released a draft guidance document outlining when certain types of software would be considered a “medical device” subject to FDA scrutiny

FDA issues draft guidance on mobile medical applications

  • King & Spalding LLP
  • -
  • USA
  • -
  • August 1 2011

The U.S. Food and Drug Administration (FDA) recently released its “Draft Guidance for Industry and Food and Drug Administration Staff on Mobile Medical Applications.”

FDA proposes medical “app” guidelines

  • Arnall Golden Gregory LLP
  • -
  • USA
  • -
  • July 27 2011

On July 21, 2011, the U.S. Food and Drug Administration (FDA) gave notice that it is seeking input on its proposed oversight approach for certain mobile applications specific to medicine or health care called “mobile medical applications” (apps), which are designed for use on smartphones and other mobile computing devices such as tablets or PDAs

FDA draft guidance on mobile apps signals increased regulatory oversight

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 27 2011

On July 20, 2011, the U.S. Food and Drug Administration (FDA) issued draft guidance identifying the mobile device applications“apps”the agency plans to regulate as medical devices

Hospital systems may be regulated as medical device manufacturers under FDA's new MDDS final rule

  • Holland & Knight LLP
  • -
  • USA
  • -
  • April 12 2011

Innovative hospitals and health care systems commonly adapt information technology to meet specific needs within their delivery systems

Upcoming cases in the United States Supreme Court’s 2010 term: Volume II

  • Larkin Hoffman
  • -
  • USA
  • -
  • February 15 2011

The Supreme Court's 2010-2011 term began in October, and it is expected to conclude by the end of April

Clinical trial registration and results posting under the Food and Drug Administration Amendments Act of 2007

  • Hogan Lovells
  • -
  • USA
  • -
  • March 3 2008

In the midst of heightened allegations regarding the suppression of unfavorable results by pharmaceutical and biotechnology companies, in September 2007, Congress significantly expanded the obligations of clinical trial sponsors to submit information regarding their trials to the federal data bank