Navigation Links
FDA Fireside Chat @ The 8th Annual MedTech Investing Conference May 6-7, 2009
Date:3/26/2009

Uniting the Venture Capital Community to Drive Innovation through Investment Opportunities in the Multi-Billion Dollar Medical Device Market

MINNEAPOLIS, March 26 /PRNewswire/ -- The 510(k) program is under siege from within and outside of the FDA. Eight scientists complained in a letter to Congress that CDRH management is overruling their scientific determinations requiring more data for 510(k)s. They followed that complaint to Congress with another letter to the Obama Administration after the election. Their argument is that CDRH is clearing 510(k)s on scant data and allowing unproven medical devices to come to the market. The New York Times did a series complaining about the same issues entitled "The Evidence Gap." Even the esteemed New England Journal of Medicine carried an article by a physician complaining about CDRH's clearance of the fractured Medtronic Sprint Fidelis defibrillator leads based upon allegedly inadequate data. Finally, the General Accounting Office (GAO) published its report on the 510(k) program and Congress is poised to hold hearings on whether the 510(k) program should change. Miriam Provost, a former Deputy Director for Science and Engineering Review in the Office of Device Evaluation (ODE) who left the Agency in 2007, was quoted in the Grey Sheets defending the Agency stating that some scientists within the Agency simply don't like the 510(k) program and are trying to make it something it is not. She said they attempt to "change the standards [for clearance] on an application-by-application basis."

This session will be feature CDRH's Don St. Pierre who has a distinguished career with CDRH starting as field engineer testing medical devices in CDRH laboratories, then he progressed to a reviewer in two divisions (Cardiovascular Devices and Reproductive, Abdominal, Ear, Nose, Throat and Radiological Devices). He has been a Branch Chief and Deputy Director of the Division o
'/>"/>

SOURCE International Business Forum, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. John Wayne Cancer Institute Auxiliary Honors Award-Winning Actress Bonnie Hunt and Philanthropists Donna & Harvey Rosen at the 24th Annual Odyssey Ball
2. Cowden Associates Releases Eighth-Annual Employee Benefit Survey Results
3. Dr. William Bill Braithwaite and Dr. John Macaulay Present Anakams Two-Factor Authentication Platform at HIMSS 2009 Annual Conference and Exhibition
4. Home Care Delivered, Inc. Recognizes 21st Annual American Diabetes Alert Day
5. Meningitis Angels to Support First Annual World Meningitis Day
6. LLE to Sponsor 16th Annual Tri-State Telecommunicators Banquet and Awards Ceremony
7. Annual Keenan Summit Addresses Challenges and Opportunities in Health Care
8. VNUS Medical Technologies to Present at the Sidoti & Company 13th Annual New York Emerging Growth Institutional Investor Forum
9. American TeleCare to Present its Wireless Wide Area Network (WWAN) Option for Cellular Telehealth Connectivity at the American Telemedicine Association (ATA) Annual Meeting
10. US trial shows no early mortality benefit from annual prostate cancer screening
11. Bionovo to Present at Wall Street Analyst Forums 20th Annual Institutional Investor Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2014)... According to a report by Fox ... knee replacement surgery on his left knee. This follows partial ... The story also reports that Bush was able to ride ... back on the bike again soon. This high level of ... knee replacement. , “Partial knee replacements give patients the ...
(Date:7/31/2014)... Hills, NY (PRWEB) July 31, 2014 ... Kim as its new board-certified plastic surgeon! , ... with helping men and women achieve the look of ... through his top procedures: breast augmentation (including ... breast or buttocks (also known as Brazilian butt lift), ...
(Date:7/31/2014)... (PRWEB) July 31, 2014 The shale ... to the top of current U.S. natural gas production ... a “boom and bust” cycle, similar to previous resource ... study released today by Washington & Jefferson College’s (W&J) ... Environmental Law Institute (ELI) confirms that the gas boom ...
(Date:7/31/2014)... Some pain relief medications can be as addictive as ... day, 46 people in the U.S. die from legal pain ... admitted to an emergency room because of opioid complications. ... of prescription and over-the-counter painkillers and is calling on the ... make these drugs safer. , The full report, “Deadly Pain ...
(Date:7/31/2014)... CA (PRWEB) July 31, 2014 Staying happy ... be tricky at best. Men and women get sucked into ... wives, life partners, and taxi services to kids. , ... offers her "3 Fast + Fun Ways to Reignite the ... download . , “This is a much better path ...
Breaking Medicine News(10 mins):Health News:George W. Bush’s Surgery Highlights the Benefits of Partial Knee Replacement 2Health News:Bellava MedAesthetics Welcomes Dr. Chang Soo Kim as Its New Westchester Plastic Surgeon 2Health News:Pennsylvania’s Shale Gas: Examining the Boom and Bust Cycle 2Health News:Pennsylvania’s Shale Gas: Examining the Boom and Bust Cycle 3Health News:Consumer Reports Warns Against the Risks of Prescription and Over-The-Counter Painkillers 2Health News:Consumer Reports Warns Against the Risks of Prescription and Over-The-Counter Painkillers 3Health News:Couples in Trouble Relationship Expert, Dr. Jackie Black, Offers a Gift Guide to Reignite the Spark So Lovers Can Kiss-And-Make-Up 2Health News:Couples in Trouble Relationship Expert, Dr. Jackie Black, Offers a Gift Guide to Reignite the Spark So Lovers Can Kiss-And-Make-Up 3
... University of Leicester have opened up a whole new ... anti-cancer drug targets, thanks to a completely new and ... Watson, Fairall and Santos, have published their research this ... a new understanding of how transcriptional repression complexes work. ...
... at Oregon State University provides evidence for the first time ... in many animals can clearly cause accelerated neurodegeneration, loss ... published in Neurobiology of Disease and done by ... to this, it wasn,t clear which came first - whether ...
... 10 (HealthDay News) -- A drug commonly used to treat ... for people older than 40 years who have Down syndrome ... Although previous animal studies of the Alzheimer,s drug, memantine, showed ... of people with Down syndrome aged 40 and older revealed ...
... (AKI) has severe consequences, with a 25 to 80 percent ... diagnose AKI using a urine test, enabling emergency departments to ... hospital. The study will be published online on January 9, ... Cardiology. Physicians typically measure a patient,s creatinine levels ...
... risk of suffering a heart attack increases by approximately 21 ... one, according to a study lead by researchers at Beth ... 9 online in the journal Circulation found the ... the first week after the death of a loved one, ...
... Maureen Salamon HealthDay Reporter , MONDAY, Jan. 9 ... migraine patients as three types of traditional acupuncture, a new ... four groups at nine Chinese hospitals -- one sham acupuncture ... of researchers, including Dr. Fan-rong Liang at Chengdu University in ...
Cached Medicine News:Health News:Unexpected discovery opens up new opportunities for targeting cancer 2Health News:Disruption of biological clocks causes neurodegeneration, early death 2Health News:Alzheimer's Med Seems Ineffective in Those With Down Syndrome 2Health News:Biomarkers identify acute kidney injury in emergency patients 2Health News:Heart attack risk rises after loss of loved one 2Health News:Power of Acupuncture to Ease Migraines Questioned in Study 2Health News:Power of Acupuncture to Ease Migraines Questioned in Study 3
(Date:7/31/2014)... , July 31, 2014 Marken announced today ... facilities to meet the clinical trial logistics growth in ... newly expanded facility will continue to serve as a ... to and from the region, and will provide additional ... Marken will combine its office and warehouse into a ...
(Date:7/31/2014)... 2014 De Pfizer Clinical Research Unit (PCRU) ... vrijwilligers van Japanse komaf voor medewerking aan klinisch onderzoek. ... is één van twee onderzoekseenheden van Pfizer , ... verbeteren door de ontdekking en ontwikkeling van nieuwe medicijnen. ... naar mannen en vrouwen van Japanse komaf – leeftijd ...
(Date:7/30/2014)... , July 30, 2014  Cepheid (Nasdaq: ... purchasing contract with Premier will end on September ... GPO will be able to continue their relationship ... HPA, MedAssets, Novation, and ROi, in addition to ... with Cepheid. "Cepheid has always recognized ...
Breaking Medicine Technology:Marken Expands Miami Regional Logistics Center 2Gezonde vrijwilligers van Japanse komaf gezocht voor deelname aan Fase I klinisch onderzoek 2Cepheid Updates Status Of Premier Group Purchasing Organization (GPO) Agreement 2Cepheid Updates Status Of Premier Group Purchasing Organization (GPO) Agreement 3
Each handle is designed to fit a specific trephine size. For use in performing free-hand uniform donor buttons....
Each handle is designed to fit a specific trephine size. For use in performing free-hand uniform donor buttons....
Each handle is designed to fit a specific trephine size. For use in performing free-hand uniform donor buttons....
Each handle is designed to fit a specific trephine size. For use in performing free-hand uniform donor buttons....
Medicine Products: