Essure Problems 

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http://gaia-health.com/gaia-blog/2012-09-20/fda-system-approves-human-testing-for-nonexistent-product-and-company/

 

http://online.wsj.com/article/SB123142562104564381.html

 

Conceptus overview

http://yahoo.brand.edgar-online.com/EFX_dll/EDGARpro.dll?FetchFilingHtmlSection1?SectionID=9148249-13357-64854&SessionID=QCdKF6MVEdrRPl7

Cindy Domescus

http://www.thefreelibrary.com/FDA+NAMES+CINDY+DOMECUS+OF+CONCEPTUS,+INC.+TO+OBSTETRICS+AND...-a016650585

 

 

Dave Buckles
Ombudsman at FDA/Center for Devices and Radiological Health
 

 

  • Public Profile www.linkedin.com/pub/dave-buckles/2/888/9b9
Background
Summary
Worked in academic medicine as a researcher in congenital heart disease, then moved to the medical device industry for several years. Since 2003 have worked at FDA in the Center for Devices and Radiological Health, first in the Division of Cardiovascular Devices and then, briefly, in Radiological Devices. Most recently, have accepted an assignment as Director of the Division of Postmarket Surveillance, tracking the performance of all medical devices in the US.

Specialties:Cardiovascular research, especially congenital heart disease and cardiac electrophysiology; in industry, Chief Scientist and Chief Technology Officer responsible for advanced product development, regulatory affairs and quality assurance, marketing, and strategic partnership negotiation; at FDA, regulation of clinical trials and marketing applications for cardiovascular and radiological devices as well as post-market surveillance.
Experience
Ombudsman FDA/Center for Devices and Radiological HealthJuly 2010 – Present (3 years 3 months)
Recently appointed as Center Ombudsman for FDA/CDRH. I'm from the government, I'm here to help. See FDA Web site at: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOmbudsman/default.htm
Division Director Food and Drug AdministrationMarch 2009 – July 2010 (1 year 5 months)
Director of Division of Device Surveillance, responsible for monitoring the performance of medical devices, searching for safety signals and acting upon findings.
Branch Chief FDADecember 2004 – March 2009 (4 years 4 months)
Front-line supervisor for the Peripheral Vascular Devices Branch, and briefly, for Product Evaluation Branch 1 and the Radiological Devices Branch. Managed teams of between 11 and 21 reviewers including scientists, engineers, medical officers, biologists, chemists, medical physicists and clerical staff.
Chief Technology Officer Quinton Medical SystemsDecember 1998 – November 2002 (4 years)
Chief Technology Officer, VP Marketing, VP Quality Systems
Education