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Results:1-10 of 24

IRS Provides Guidance on Suspension of Medical Device Excise Tax
  • Latham & Watkins LLP
  • USA
  • March 11 2016

On February 24, 2016, the Internal Revenue Service (IRS) published informal guidance on the suspension of the Medical Device Excise Tax through an


FDA to strengthen oversight of certain in vitro diagnostic devices
  • Latham & Watkins LLP
  • USA
  • August 20 2014

On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to strengthen regulation of certain in vitro diagnostics


Medical device IDEs: FDA continues effort toward greater efficiency and transparency
  • Latham & Watkins LLP
  • USA
  • July 17 2013

In June, 2013, the Food and Drug Administration (FDA) announced the availability of a new draft guidance document, “Draft Guidance for Industry


FDA issues draft guidance on "content of premarket submissions for management of cybersecurity in medical devices"
  • Latham & Watkins LLP
  • USA
  • July 15 2013

On June 14, 2013, the Food and Drug Administration ("FDA") issued a draft guidance entitled, "Content of Premarket Submissions for Management of


The Food and Drug Administration Safety and Innovation Act of 2012: assessing the impact on the medical device industry
  • Latham & Watkins LLP
  • USA
  • July 17 2012

On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) into law.


Medical device benefit-risk determinations: FDA releases a novel guidance giving industry an inside view of agency decision-making
  • Latham & Watkins LLP
  • USA
  • April 12 2012

On March 27, 2012, the Food and Drug Administration (FDA or Agency) released a final guidance describing the principal factors the it considers when making benefit-risk determinations in the medical device premarket review process.


The Institute of Medicine recommends FDA abandon the 510(k) premarket clearance process
  • Latham & Watkins LLP
  • USA
  • August 2 2011

In September 2009, the US Food and Drug Administration (FDA or Agency) requested that the Institute of Medicine (IOM) evaluate the premarket clearance process for medical devices set forth in section 510(k) of the Federal Food, Drug and Cosmetic Act.


FDA issues draft guidance for in vitro companion diagnostic devices
  • Latham & Watkins LLP
  • USA
  • July 20 2011

On July 14, 2011, the Food and Drug Administration (FDA) issued a draft guidance entitled, "In Vitro Companion Diagnostic Devices."


FDA moves to clarify nanotechnology guidelines
  • Latham & Watkins LLP
  • USA
  • June 20 2011

Nanotechnology the use of nanometer-sized particles in consumer and other products has been at the forefront of commercial innovation across several industries over the past decade, from personal care products to pharmaceuticals.


Matrixx Initiatives, Inc. v. Siracusano: changes in adverse event reporting
  • Latham & Watkins LLP
  • USA
  • April 7 2011

On March 22, 2011 the US Supreme Court issued its decision in Matrixx Initiatives, Inc. v. Siracusano, in which it rejected the application of a bright-line rule that reports of adverse events related to the use of drugs and other products regulated by the US Food and Drug Administration (FDA) which do not rise to the level of statistical significance are immaterial as a matter of law under the federal securities laws.