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:8/21/2014)... , Aug. 21, 2014 The spinal column ... the human body. Signals carried to and from the brain ... skills and nervous system. Injury or ailment here can be ... with a loss of control over their body. Though back ... a person,s life, there are more options available to make ...
(Date:8/21/2014)... 21, 2014 /PRNewswire-iReach/ -- Inc. magazine ... the third straight year, No. 349 in Health ... ranking of the nation,s fastest-growing private companies. The ... most important segment of the economy—America,s independent entrepreneurs. ... Pizza, LinkedIn, Zillow, and many other well-known names ...
(Date:8/21/2014)... 21, 2014 BreedIT Corp., ... the exclusive worldwide license holder and distributor of ... and researchers, today is pleased to announce the ... Seach Ltd, a leading Israeli medical Cannabis breeder. ... develop new breeds of medical Cannabis to meet ...
Breaking Medicine Technology:Don't Live in Pain: Four Life Improving Benefits of Back Surgery 2Carolina's HME Named for Third Straight Year to Inc. Magazine's List of America's Fastest-Growing Private Companies--the Inc. 5000 2Carolina's HME Named for Third Straight Year to Inc. Magazine's List of America's Fastest-Growing Private Companies--the Inc. 5000 3BreedIT Ltd. and Seach Ltd. Form KanaboSeed to Develop New Medical Cannabis Varieties 2BreedIT Ltd. and Seach Ltd. Form KanaboSeed to Develop New Medical Cannabis Varieties 3BreedIT Ltd. and Seach Ltd. Form KanaboSeed to Develop New Medical Cannabis Varieties 4
(Date:8/22/2014)... Las Vegas, NV (PRWEB) August 22, 2014 ... that teaches readers how they can use natural methods ... for years has caught the attention of Shane Michaels, ... only a condition that affects the skin, it can ... suffer from it,” reports Michaels. “The intense itching and ...
(Date:8/22/2014)... found in the circulating free tumor DNA (ctDNA) from ... patients correlates well with the EGFR mutations from patient-matched ... therapy is approved for EGFR activating mutation positive patients ... status is with DNA derived directly from tumor tissue, ... abundant and less invasive source of tumor DNA may ...
(Date:8/22/2014)... Advancements in ultrasound technologies make ... due to their cost-effectiveness, non-invasiveness, and absence of ... such as the evolution of wireless transducers and ... market moving throughout 2014 and beyond. Such Ultrasound’s ... only the point-of-care (POC) testing in hospital settings, ...
(Date:8/22/2014)... 2014 CarePoint Health is proud ... Medicine, Geriatrics, Hospice and Palliative Care, Dr. Michelle ... Group. Their system welcomes Dr. Reisner to the ... comprise CarePoint Health Medical Group, a comprehensive network ... representing a wide range of specialties. This latest ...
(Date:8/22/2014)... 22, 2014. A new study of self-awareness ... multiple sclerosis (MS) may be able to improve ... was epublished ahead of print on July 2 ... Hali Griswold, Nancy D. Chiaravalloti & John DeLuca: ... multiple sclerosis doi: 10.3233/NRE-141113). Self-awareness is one,s ability ...
Breaking Medicine News(10 mins):Health News:Beat Eczema: Review Exposes Susan Clark’s Guide to Curing Eczema Naturally 2Health News:High concordance between EGFR mutations from circulating-free tumor DNA and tumor tissue in non-small cell lung cancer 2Health News:Global Top Ultrasound Market Suppliers Assessed in New VPG Research Report Available at MarketPublishers.com 2Health News:Global Top Ultrasound Market Suppliers Assessed in New VPG Research Report Available at MarketPublishers.com 3Health News:Dr. Reisner Joins CarePoint Health Medical Group 2Health News:Kessler Foundation study of self-awareness in MS has implications for rehabilitation 2
... , TUESDAY, March 20 (HealthDay News) -- Small ... healthier foods after changes to a popular U.S. government food-aid ... Program for Women, Infants and Children (WIC program) is tailored ... new mothers, as well as infants and children up to ...
... By Carina Storrs HealthDay Reporter , TUESDAY, ... moments that women say they experience during menopause may be ... new study suggests. Researchers gave women who said they ... see how well their abilities matched their complaints. Sure enough, ...
... Kathleen Doheny HealthDay Reporter , TUESDAY, March 20 ... a healthy woman,s overall risk of heart failure one way ... decreases the risk," said study author Dr. Claudia Chae, a ... in the March 20 issue of Circulation: Heart Failure ...
... Diseases such as kidney failure and endocrine tumors are ... could the common pain relievers in your medicine cabinet ... of Tel Aviv University,s Sackler Faculty of Medicine and ... medications are underlying causes of hypertension, which is a ...
... -- Some people are more likely than others to have ... their brain, according to a new study. Researchers examined ... of alcohol-related blackouts and 12 people without a history of ... task with and without alcohol. The findings are published ...
... evidence links Alzheimer,s disease and diabetes , An ... be linked to insulin resistance, constituting a third type ... including an increased risk of developing Alzheimer,s disease for ... tissue of Alzheimer,s disease patients. Though intriguing, the existing ...
Cached Medicine News:Health News:Corner Stores Stock Healthier Foods After Aid Program Changes 2Health News:Study Suggests Mental 'Fog' of Menopause Is Real 2Health News:Study Suggests Mental 'Fog' of Menopause Is Real 3Health News:Vitamin E Supplements Don't Affect Heart Failure Risk: Study 2Health News:Vitamin E Supplements Don't Affect Heart Failure Risk: Study 3Health News:Pain relievers could be spiking your blood pressure 2Health News:JCI early table of contents for March 26, 2012 2Health News:JCI early table of contents for March 26, 2012 3Health News:JCI early table of contents for March 26, 2012 4Health News:JCI early table of contents for March 26, 2012 5Health News:JCI early table of contents for March 26, 2012 6
... The 1081 is an all-in-one drape ... The drape includes a pouch with filter ... finger cot. 64 inches (164cm) TUR ... Elastic aperture, Neoprene finger cot, Fluid collection ...
... Both the Penilab IV and the Penilab V ... studies. Model 1060 is similar to the Model ... nor can one be added later. The Penilab ... including all of the accessories you'll need to get ...
The Model 240 is a single-channel instrument designed for penile tumescence monitoring. It features exceptional stability. It's ready for use with most multi-channel recorders having a DC input....
... II SP MRI-Compatible Anesthesia System is perfect for ... than one type of anesthetic agent. , ... due to its wider stance, has a larger ... bellows assembly is utilized in both the Integra ...
Medicine Products: