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21st Century Cures Act Signed into Law by President Obama
  • Squire Patton Boggs
  • USA
  • December 14 2016

On December 13, 2016, President Barack Obama signed H.R. 34, the 21st Century Cures Act, into law. This sweeping healthcare law addresses the

Let’s Get Real: Meredith Manning Urges FDA to Allow Greater Communication of Real World Data Within Its Current Regulatory Framework
  • Hogan Lovells
  • USA
  • November 7 2016

On October 26, 2016, Hogan Lovells partner Meredith Manning submitted a comment to the U.S. Food and Drug Administration (FDA) urging the agency to

Draft Law Envisages New Punishments for Healthcare Violations
  • Baker McKenzie
  • Russia
  • July 5 2016

A draft law either establishing or strengthening administrative liability for certain violations in the field of healthcare is currently under review

China Issues First Update to Medical Device Clinical Trial Guidelines in 12 Years
  • Knobbe Martens
  • China
  • March 31 2016

The Chinese Food and Drug Administration (“CFDA”) recently announced its first update to the medical device clinical trial guidelines in 12 years

China FDA Announces Good Clinical Practices for Medical Devices
  • Ropes & Gray LLP
  • China
  • March 28 2016

On March 23, 2016, the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission jointly promulgated the

U.S. medical device approval system under review
  • Torys LLP
  • USA
  • August 24 2011

On July 29, 2011, the Institute of Medicine (IOM)1 released its long-awaited report on the 510(k) process, under which companies wishing to introduce new medical devices to the United States are permitted to demonstrate that their devices are similar to those already on the market (“predicate devices”) and thereby avoid having to undergo clinical trials and other means of extensive testing required through the pre-market approval process.

Is your smart phone an FDA-regulated medical device?
  • Jones Day
  • USA
  • August 3 2011

An enormous number of software applications have been developed for use on handheld computers such as smart phones, tablet computers, and personal digital assistants.

Cross-Strait Medical and Healthcare Cooperation Agreement
  • Formosa Transnational
  • Taiwan, China
  • April 20 2011

Following the ongoing trend of cross-strait cooperation, Taiwan and China have signed the Cross-Strait Medical and Healthcare Cooperation Agreement.

FDA announces actions designed to improve the 510(k) premarket clearance process
  • Latham & Watkins LLP
  • USA
  • January 27 2011

On Wednesday, January 19, 2011, the FDA released a plan to improve the current 510(k) program by announcing 25 action items "it intends to implement during 2011 to improve the most common path to market for medical devices."

FDA revises informed consent regulations to incorporate clinical trial registration requirements
  • Latham & Watkins LLP
  • USA
  • January 7 2011

On Tuesday, January 4, 2011, the U.S. Food and Drug Administration (FDA) issued a Final Rule amending the current informed consent regulations pursuant to the requirements of the Food and Drug Administration Amendments Act of 20072 (FDAAA).