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:12/17/2014)... parents should leave prenatal picture-taking to medical professionals, the ... ultrasound imaging and heartbeat monitors to get "keepsake" images ... "Although there is a lack of evidence ... monitors, prudent use of these devices by trained health ... engineer, said in an agency news release. "Ultrasound ...
(Date:12/17/2014)... HealthDay Reporter TUESDAY, Dec. ... fast approaching, a new study reveals that states that routinely ... drunk drivers on their roads. The finding suggests that ... able to deter inebriated revelers from getting behind the wheel ... being passed regarding drinking and driving," said study lead author ...
(Date:12/15/2014)... 2014 A recent survey found that ... as impacting skin health and beauty were: “Connections,” “climate,” ... care.” Water and health advocate and radio host Sharon ... describing the survey and the Four C’s.* Kleyne notes, ... category discussed would benefit from paying attention to one’s ...
(Date:12/15/2014)... December 15, 2014 Main Street Dental ... is weighing in on a new study providing evidence ... the oral hygiene of children. , Sufficient enough evidence ... such as pop or juice drinks, with the onset ... however, is whether drinks listed as 100% fruit juice, ...
(Date:12/15/2014)... 2014 OutMarket , a provider ... Social Media Cheat Sheets ,” a guide that exposes ... results on the top ten social media networks. ... drive awareness, engagement, and customer service. It can also ... an impact on new networks and weather constantly changing ...
Breaking Medicine News(10 mins):Health News:FDA Warns Against Fetal 'Keepsake' Videos 2Health News:Enforcement of Drunk Driving Laws Makes Roads Safer, Study Finds 2Health News:Enforcement of Drunk Driving Laws Makes Roads Safer, Study Finds 3Health News:Water and health advocate Sharon Kleyne adds a “W” for fresh water to “four C’s of skin care” 2Health News:Water and health advocate Sharon Kleyne adds a “W” for fresh water to “four C’s of skin care” 3Health News:Main Street Dental Team, Unionville’s Most Innovative Dental Clinic, Comments on New Study Relating Pure Fruit Juice to Poor Oral Hygiene 2Health News:OutMarket Releases Cheat Sheets for Social Media Marketing 2Health News:OutMarket Releases Cheat Sheets for Social Media Marketing 3
... through in the medical field was seen when Pharma major ... who were the instigators for the vaccine//, marketed the latest ... in India and various measures are to be taken to ... a virus which has an incubation period of almost a ...
... quarrels and arguments can delay wound healing according to a ... edition of New Scientist//. ,.,Researchers at Ohio State University ... arguments for about half hour daily can have delayed wound ... problems can also cause reduced body immunity. ,42 married ...
... which intends to stabilize the rates of HIV by the ... US dollars to HIV infected individuals on a monthly basis//. ... HIV infection to below 0.3 percent by 2010. The current ... ,Under a recent government decision, poor HIV carriers living ...
... patient with Her-2/neu positive was helped by her Wangaratta ... drug which costs her more than $70,000.// The fund ... community which could help her to buy Herceptin drug ... more resistant to chemotherapy and anti-estrogen therapy such as ...
... a novel finding that love and addiction may go ... the physiological effects manifested as a result of dopamine ... more than a simulation of the effects observed following ... love and drug abuse leaves the user with an ...
... program with safe and tolerable exercise can be given ... them to have a better heart function//. The study ... of Cardiologist, Jonathan Rhodes. ,The study was ... 8 to 17 with severe congenital heart disease and ...
Cached Medicine News:Health News:‘Marriage Squabbles’ bad for both Emotional and Physical Wound 2Health News:Love And Drug Addiction Share The Same Chemistry 2
(Date:12/17/2014)... 17, 2014  Northstar Global Business Services, Inc. ... (DTC) has made their final decision and has ... Company,s stock effective December 15, 2014, and has ... depository and book entry transfer services. All deposit restrictions ... once again fully "DTC Eligible", and has resumed ...
(Date:12/17/2014)... SCOTTSDALE, Ariz. , Dec. 17, 2014 /PRNewswire/ ... of state-of-the-art interactive music products, today announced that ... Ltd, a leading manufacturer and supplier of innovative ... As part of the agreement, RSL ... Facility bundled solution specifically configured for use within ...
(Date:12/17/2014)... LOS ANGELES , Dec. 17, 2014 /PRNewswire/ ... that the US Patent and Trademark Office (USPTO) ... candidate ICT-107, a dendritic cell-based immunotherapeutic vaccine targeting ... glioblastoma. The claims of US Patent No. 8,871,211, ... treating neural cancer by administering a dendritic cell ...
Breaking Medicine Technology:Northstar announces that the DTC chill on MDIN has been officially lifted 2Northstar announces that the DTC chill on MDIN has been officially lifted 3Beamz Interactive, Inc. Signs UK Distribution Agreement with RSL Steeper Limited 2Beamz Interactive, Inc. Signs UK Distribution Agreement with RSL Steeper Limited 3ImmunoCellular Therapeutics Announces Issuance of Key Patent For ICT-107 Cancer Vaccine 2
...
...
Ascent Primary Knee System with cruciate retaining, posterior stabilized and constrained components...
Ascent Primary Knee System with cruciate retaining, posterior stabilized and constrained components...
Medicine Products: