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:1/15/2014)... , Jan. 15, 2014 MultiCell Technologies, Inc. (OTC ... U.S. provisional patent application concerning composition of matter, biological ... targeted tumor cell death.  This patent ... double stranded RNA molecules (VSRNAs) which interfere with the ...
(Date:1/15/2014)... 15, 2014  According to Millennium Research Group (MRG), ... the United States and ... will expand moderately through 2022, with embolization particles ... increasing interest in drug-eluting beads (DEBs) and radioembolization ...
(Date:1/15/2014)...  Valeant Pharmaceuticals International, Inc. (NYSE: VRX ... under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 ("HSR") ... its indirect wholly-owned subsidiary, Sapphire Subsidiary Corp. ("Purchaser"), for ... Solta Medical, Inc. (NASDAQ: SLTM ) ("Solta") ...
Breaking Medicine Technology:MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 2MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 3US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 2US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 3Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 2Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 3
... Belgium, December 12, 2011 The peer ... of a clinical trial demonstrating the sedative action of the ... whose abstract is available from the US National Libretry of ... http://www.ncbi.nlm.nih.gov/pubmed/22035386 The results show, ...
... FRANCISCO, Calif., Dec. 10, 2011  Onyx Pharmaceuticals, Inc. (Nasdaq: ... poster presentations of single-agent carfilzomib, a next generation proteasome ... at the 53rd American Society of Hematology (ASH) Annual ... expanded data set supports our belief in the potential ...
Cached Medicine Technology:Insomnia: A No-Drug Solution? 2Onyx Pharmaceuticals Provides Update on Carfilzomib at 53rd American Society of Hematology Annual Meeting 2Onyx Pharmaceuticals Provides Update on Carfilzomib at 53rd American Society of Hematology Annual Meeting 3Onyx Pharmaceuticals Provides Update on Carfilzomib at 53rd American Society of Hematology Annual Meeting 4Onyx Pharmaceuticals Provides Update on Carfilzomib at 53rd American Society of Hematology Annual Meeting 5Onyx Pharmaceuticals Provides Update on Carfilzomib at 53rd American Society of Hematology Annual Meeting 6
(Date:4/23/2014)... compound that targets an important brain receptor has a ... including relapse behavior, a University at Buffalo animal study ... this may be a novel lead compound for treating ... UB research was published as an online preview article ... study, the compound, RO5263397, severely blunted a broad range ...
(Date:4/23/2014)... methods that can rapidly screen a large cell ... inside that population has been seriously lacking," said ... the Royal Society of Chemistry journal Chemical ... his coworkers have developed a novel technique that ... Chem. Sci. , 2014, DOI: 10.1039/C4SC00578C, http://pubs.rsc.org/en/content/articlelanding/2014/sc/c4sc00578c#!divAbstract ...
(Date:4/23/2014)... as the United States, it may come as a surprise ... adequate food due to lack of money or other financial ... the University of Illinois using data from the National Health ... are dealing with hunger are also facing negative health and ... over age 60 faced the threat of hungerthat translates to ...
(Date:4/23/2014)... of Midlife Occupational and Leisure Time Physical Activity on ... activity in midlife increases the risk of mobility limitation ... risk. This is found in a study which followed ... study was conducted at the Gerontology Research Center in ... Heavy physical labor is often repetitive, wears the body ...
(Date:4/23/2014)... has been a rapidly evolving pursuit with many ... in the research road, scientists have found a ... with the disease. The report, which appears in ... have important implications for developing novel treatments. , ... that for years, research has suggested a link ...
Breaking Medicine News(10 mins):Health News:Novel compound halts cocaine addiction and relapse behaviors 2Health News:Following a protein's travel inside cells is key to improving patient monitoring, drug development 2Health News:More Americans in their golden years are going hungry 2Health News:Midlife occupational and leisure-time physical activity limits mobility in old age 2
... a recent study that came out in the journal Environmental ... plastics on human beings. ,Bisphenol-A (BPA) is a ... grade materials for making air tight containers, drinking water bottles, ... of Medicine did the study to find out about the ...
... that spreads through mosquito bites, among other things, did not ... of Nature Medicine scientists have shown a successful treatment on ... developed an antibody that can successfully fight the virus. The ... naturally against this virus and in turn never get affected ...
... study made by researchers of UK, scientists have found that ... the blood of the passengers. ,The study was done ... today, do have any effect on the health of the ... peripheral oxygen saturation and pulse rate of 84 passengers, aged ...
... cure people suffering from hay fever by teaching them self-hypnosis.//,The ... curing allergic reactions. 79 patients of an average age of ... or pollen were taken in the study. All these people ... years. Random parallel group was used as control for the ...
... to be a risk factor for multiple sclerosis. New ... more in people suffering from multiple sclerosis. ,In ... of medicine, researchers had been able to associate habitual ... sclerosis. In a study comprising of 201 cases of ...
... addiction is a problem because the addicts find it hard ... this type of behavior may be that drugs affect the ... towards other rewards of life, like eating and fulfilling of ... treat drug addiction may be a surgical procedure by which ...
Cached Medicine News:
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: