Navigation Links
Findings From Largest Industry Assessment of 510(k) Process to be Released on May 24, 2011
Date:5/18/2011

WASHINGTON, May 18, 2011 /PRNewswire/ --

What:  Investigators from Northwestern University will release a new, in-depth analysis of FDA's 510(k) regulatory pathway—through which more than 90% of medical devices receive clearance—and of industry's practices within it. The study is the most comprehensive survey to date about the 510(k) process.

FDA's Center for Devices and Radiological Health (CDRH) is currently weighing regulatory revisions that support innovation; bring important, safe, and effective technologies to patients quickly; and keep jobs in the United States. The agency has also commissioned the Institute of Medicine (IOM) to produce an independent review panel report, which will be released this summer.

The Northwestern findings—based on survey responses from more than 350 medtech product designers and developers, entrepreneurs, academic physician inventors, and regulatory affairs professionals—are expected to help identify key opportunities for improving FDA's product review process.

The survey is part of "A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform," a study funded by the Institute for Health Technology Studies (InHealth), a nonprofit foundation that supports research and analysis into the role of medical technology in advancing healthcare and patient quality of life.

Who:  Survey findings will be presented by investigators John H. Linehan, PhD, professor of biomedical engineering at Northwestern University, and Jan B. Pietzsch, PhD, president and CEO of Wing Tech Inc., a technology consultancy, and a consulting associate professor in Stanford University's Department of Management Science and Engineering, and the Biodesign Program.

Robert J. Rubin, MD, clinical professor of medicine at Georgetown University and chair of InHealth's Research Council, will mod
'/>"/>

SOURCE The Institute for Health Technology Studies (InHealth)
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Researchers Present Key Findings Comparing PEM to MRI for Identification of Contralateral Breast Cancer at the National Consortium of Breast Centers (NCBC) Conference
2. Positive Findings From Excellagen Matrix Clinical Study Published in Peer-Reviewed Journal Wound Repair and Regeneration
3. Alere Previews Findings from Key Research Study on Medication Adherence at Integrated Benefits Institute Conference
4. Cancer Patients May Reduce Fast Growing Breast Cancer Recurrences: Findings Reported at 2010 San Antonio Breast Cancer Symposium
5. New York Robotic Surgery Expert Dr. David Samadi, MD Discusses New Findings that Hormone Therapy May Increase Risk of Developing Colorectal Cancer
6. Biodel Reports New Findings from Key Programs at Diabetes Technology Meeting
7. Cardium Announces New Research Findings: Excellagen Product Candidate Activates Platelet Release of PDGF, an Important Growth Factor Fundamental to the Wound Healing Process
8. Ground Breaking Findings on Understanding Cancer Published in the Current Issue of Science
9. Metabolic Solutions Development Company to Present Research Findings to European Association for the Study of Diabetes
10. Trius Reports New Findings on Mechanisms of Antibiotic Resistance in MRSA
11. New Study Findings Could Help Millions Who Suffer From Dry Mouth: Over-The-Counter Muco-Adhesive Patch Outperforms Leading Oral Rinse
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... MYERS, Fla. , Jan. 23, 2015  Today the ... of Novartis, Bexsero® for the prevention of serogroup ... 25. Bexsero and Pfizer,s vaccine Trumenba®, which received FDA ... helping prevent this devastating disease. "I ...
(Date:1/23/2015)... DES MOINES, Iowa , Jan. 23, 2015  The Partnership to ... Iowa health care leaders and a new study ... prescription medications. The PFCD is a nationwide coalition working to educate ... The research released at the Capitol was focused on how the ...
(Date:1/23/2015)... , Jan. 23, 2015 More than a third of ... of those with private insurance, filled a prescription for an ... report in this week,s Morbidity and Mortality Weekly Report (MMWR). ... providers to treat moderate to severe pain.  They are also ...
Breaking Medicine Technology:The National Meningitis Association (NMA) Applauds FDA Approval of Second Vaccine To Protect Against Serogroup B Meningococcal Disease 2New research shows Iowa health exchange would benefit from improvements 2New research shows Iowa health exchange would benefit from improvements 3Opioid painkillers widely prescribed among reproductive age women 2Opioid painkillers widely prescribed among reproductive age women 3
(Date:1/22/2015)... Autocarinsurancebest.com has released a new blog post explaining the ... . , Auto insurance quotes help many drivers find ... necessary to call an agent or visit an agency for ... single website: http://autocarinsurancebest.com/ . , Every business who relies ...
(Date:1/22/2015)... NJ (PRWEB) January 22, 2015 Joan ... and keynote speaker at the upcoming 32nd Annual ... ACCME-accredited Physicians’ Education Resource®, LLC (PER®) , shares ... would have gone undetected if she had not followed ...
(Date:1/22/2015)... Recently, Weddingshe.com has added many trendy Champagne wedding ... annual revenues in the past three years. Today, the business ... , According to the sales manager of the company, this ... in 2015. This point can be reflected on the discounted ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 Payday lending ... vulnerable communities and cause financial distress to the states ... analysts at Howard University’s Center on Race and Wealth. ... in economic activity, payday loans at the same time ...
(Date:1/22/2015)... 2015 JJsHouse.com is a famous dress online ... business announces its latest collection of wedding dresses , ... important issue is the wedding dress on your big day; ... woman’s life. Every bride wants to find the most suitable ...
Breaking Medicine News(10 mins):Health News:Commercial Auto Insurance Provides Several Important Features! 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 5Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 6Health News:Weddingshe Announces A Special Offer On Its Popular Glamorous Wedding Dresses 2Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2Health News:Find The Most Suitable Wedding Dress At JJsHouse.com 2
... 26 (HealthDay News) -- ,Researchers who identified a new ... discovery could lead to targeted treatment for the deadly ... Cancer Center screened samples from 287 patients with gastrointestinal ... (IDH1 and IDH2) may account for nearly one-fourth of ...
... HealthDay Reporter , THURSDAY, Jan. 26 (HealthDay News) -- The ... cancers still fall below national targets, federal health officials said ... screened for breast cancer, below the target of 81 percent, ... the target is 93 percent, and for colon cancer 58.6 ...
... program requiring all businesses to eliminate workplace hazards ... it is adequately enforced, according to a new study ... the California Injury and Illness Prevention Program found evidence ... businesses that had been cited for not addressing the ...
... , THURSDAY, Jan. 26 (HealthDay News) -- People who work ... a new study. Researchers followed roughly 2,000 middle-aged ... depression into account, found that workers on the job for ... to suffer from depression as those who work just seven ...
... changes women,s estrogen levels and has different effects in Asian ... women, ages 18 to 44, took part in the study between ... a day, about the equivalent of one cup of caffeinated coffee. ... Asian women who consumed an average of 200 milligrams or ...
... Medical Center researchers have discovered new links between leukemia ... fresh perspective on how the blood cancer progresses and ... help in the treatment of leukemia., The research, led ... P. Wilmot Cancer Center laboratory of corresponding author Laura ...
Cached Medicine News:Health News:Researchers Spot Potential Bile Duct Cancer Drug Targets 2Health News:Too Few Americans Getting Screened for Common Cancers: CDC 2Health News:Too Few Americans Getting Screened for Common Cancers: CDC 3Health News:Workplace safety program can reduce injuries if aggressively enforced, study finds 2Health News:Workplace safety program can reduce injuries if aggressively enforced, study finds 3Health News:Caffeine May Alter Women's Estrogen Levels 2Health News:URMC finds leukemia cells are 'bad to the bone' 2Health News:URMC finds leukemia cells are 'bad to the bone' 3
Bandeau Bra...
Compression Bra...
... (ACB®) Test is a clinical chemistry assay ... measuring the cobalt binding capacity of albumin ... in the early 1990s, IMA is produced ... ischemic tissue in the heart. During ischemia, ...
Our Osteomark® ELISA kits provide a quantitative measurement of cross-linked N-telopeptides of type I collagen (NTx) as an indicator of bone resorption, with higher levels in serum or urine sampl...
Medicine Products: