FDA Voice blog

By: Ben Fisher, Ph.D. At the FDA, we recognize the value of encouraging medical device innovation. We recently have acted to reduce the time and cost of clinical trials while maintaining patient protections. By doing so, FDA is helping to ensure that manufacturers will be more likely to conduct their clinical studies in the U.S.,…

Consumer Information on: activL® Artificial Disc

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Meeting Notice: September 24, 2015 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting

 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0736] Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY:  Food and Drug Administration, HHS. ACTION:  Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA).  The meeting…

Public Workshop – Medical Device Patient Labeling, September 29

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Medical Device Patient Labeling”. The purpose of the public workshop is to discuss issues associated with the development and use of medical device patient labeling including content, testing, use, access, human factors, emerging media formats, and promotion and advertising. The Center for Devices…

Emergency Use Authorizations (Added the RealStar® MERS-CoV RT-PCR Kit U.S.

On November 10, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the RealStar® Ebolavirus RT-PCR Kit 1.0 for the presumptive detection of RNA from Ebolaviruses [such as Zaire ebolavirus (including the Zaire ebolavirus strain detected in the West Africa outbreak 2014), Sudan ebolavirus, Tai Forest ebolavirus, Bundibugyo ebolavirus,…

Robotically-Assisted Surgical Devices (RASD)Workshop Agenda

The Food and Drug Administration (FDA) is announcing a public Workshop entitled: “Robotically-Assisted Surgical (RAS) Devices: Challenges and Opportunities.” The purpose of this workshop is to obtain public feedback on scientific, clinical and regulatory considerations associated with RAS devices. Comments and suggestions generated through this workshop will facilitate further development of regulatory science for RAS…