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Results: 1-10 of 89

FDA Issues Final Rule on Data Acceptance from Clinical Investigations for Medical Devices
  • Morgan Lewis
  • USA
  • February 27 2018

The US Food and Drug Administration's new requirements for sponsors to follow Good Clinical Practices (GCPs) for ex-US device clinical trials will


Moratorium on Medical Device Excise Tax Extended for Two Years
  • Morgan Lewis
  • USA
  • January 25 2018

With the passage on January 22 of continuing appropriations through February 8 (HR 195), the moratorium on the medical device excise tax has been


Asia Chronicle: Issue 9 October - December 2017
  • Morgan Lewis
  • Asia-Pacific, Singapore, China
  • December 28 2017

Since the Personal Data Protection Act 2012 (PDPA) came into full effect on 1 January 2014, the Personal Data Protection Commission (PDPC) has


CFDA Issues New Classification Catalogue for Medical Devices In China
  • Morgan Lewis
  • China
  • October 23 2017

The new catalogue, which becomes effective on August 1, 2018, is likely to have a significant impact on the registration, manufacturing, operation


FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months
  • Morgan Lewis
  • USA
  • February 13 2017

Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration's (FDA's or the Agency's) Center for


FDA Issues Final Guidance on “Emerging Signals”
  • Morgan Lewis
  • USA
  • December 21 2016

On December 14, 2015, the FDA issued a final guidance titled "Public Notification of Emerging Postmarket Medical Device Signals" (Final Guidance


FDA Uses Summer to Issue Numerous Device Guidance Documents
  • Morgan Lewis
  • USA
  • August 31 2016

Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active


FDA issues final guidance for general wellness devices
  • Morgan Lewis
  • USA
  • August 1 2016

On July 29, the US Food and Drug Administration (FDA) announced the availability of its guidance document, General Wellness: Policy for Low Risk


FDA clarifies policy for sharing patient-specific data from devices
  • Morgan Lewis
  • USA
  • June 15 2016

With the increased use and availability of remote monitoring and wearable devices, device manufacturers are collecting an extensive amount of


FDA issues “leapfrog” draft guidance for 3d Printing of medical devices
  • Morgan Lewis
  • USA
  • May 19 2016

In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or Agency) issued a