Navigation Links
FDA to Improve Most Common Review Path for Medical Devices
Date:1/19/2011

, CDRH also asked the independent, nonprofit Institute of Medicine to study the program.  That review is still underway.

In a transparent effort, CDRH sought public input during both the development and review of the two internal reports. The center held two public meetings in the Washington area and separate "town hall" meetings in Minneapolis, Boston and Los Angeles. The FDA also received 76 written comments to three public dockets from industry members, health care professional organizations, consumer groups, patient groups, third-party payers, venture capital groups, agency staff, trial lawyers, foreign regulatory bodies, law firms, individual members of the public, consulting firms and academic institutions.

The two working groups issued 55 recommendations in August 2010. After reviewing public comment, CDRH now intends to take 25 actions to improve the 510(k) program in 2011, including new guidance and enhanced staff training. CDRH also is giving the Institute of Medicine an opportunity to provide feedback on seven recommendations before making a final decision and is planning for a public meeting in April to seek additional feedback on two other recommendations.

Dr. Shuren announced the action plan today in an open letter to the public. "We look forward to implementing these changes in support of our overall mission: improving the health of the American public," he said.

For more information

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA




'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Study Suggests High-Dose Fish Oil May Significantly Improve Behavior in Children with ADHD
2. Nexavar Significantly Improved Overall Survival in Phase 3 Asia-Pacific Liver Cancer Trial
3. Experimental Drug Ketasyn(TM) Improves Memory in Age-Associated Memory Impairment Study
4. Study Shows Combination Therapy Incorporating AVODART(R) and Tamsulosin Provides Continuous Symptom Improvement Over 2 Years
5. First Osteoporosis Study in Hip Fracture Patients Finds Once-Yearly Reclast(R) Prevents Additional Fractures and Improves Survival
6. One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function
7. One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function
8. Promising Phase 3 Trial Results Show Novel Biologic Therapy Ustekinumab (CNTO 1275) Significantly Improved Psoriasis
9. Surgeons Find That Laparoscopic Banding Procedure Helps Overweight Adolescents Lose Weight and Improve Health
10. KineMed Presents Preclinical Data for Investigational Agent Demonstrating Neurogenesis and Confirming Improvements in Behavioral Model
11. Boston Scientifics Next-Generation Stent Shows Improved Clinical Outcomes in Complex Lesions
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... 2014  United Therapeutics Corporation (NASDAQ: UTHR ... the District of New Jersey ... against Sandoz, Inc. regarding United Therapeutics, Remodulin ® ... that U.S. Patent No. 6,765,117 is both valid and ... its generic product until the expiration of that patent ...
(Date:8/29/2014)... Aug. 29, 2014 Diseases largely eradicated in ... ago are returning. Measles was declared eliminated in 2000, ... as of August 15—the highest incidence in 20 years. ... department declared whooping cough a problem of "epidemic ... sick and dying from these preventable diseases—in part because ...
(Date:8/29/2014)... 2014 Research and Markets has ... Drugs Market 2014-2018" report to their offering. ... condition that results in demyelination, axonal transection, and neurodegeneration. ... response by the immune system, which targets neurons within ... debilitating disease in which the damage of the myelin ...
Breaking Medicine Technology:District Court Decision Received In Remodulin Patent Case 2Vaccines at the Crossroads: Outbreaks On the Rise Across America 2Vaccines at the Crossroads: Outbreaks On the Rise Across America 3Global Multiple Sclerosis Drugs Market 2014-2018: Key Vendors are Bayer, Biogen Idec, Merck Serono, Novartis and Teva Pharmaceutical 2Global Multiple Sclerosis Drugs Market 2014-2018: Key Vendors are Bayer, Biogen Idec, Merck Serono, Novartis and Teva Pharmaceutical 3
... China, April 16, 2011 China Medical Equipment ... provider of ultrasound and MRI systems in China, ... portable ultrasound machine. The iuStar100 utilizes Samplify,s high-performance, ... SAM1600 analog to digital converter (ADC) to deliver ...
... Md., April 15, 2011 The U.S. Food and ... or in combination with methotrexate, for the treatment ... children ages 2 years and older. ... Still,s disease, is a rare, potentially life-threatening disorder ...
Cached Medicine Technology:United Imaging Healthcare Leverages Samplify's Analog Front-End Solutions to Deliver New Portable Ultrasound System with Superior Image Quality 2FDA Approves Actemra to Treat Rare Form of Juvenile Arthritis 2FDA Approves Actemra to Treat Rare Form of Juvenile Arthritis 3
(Date:9/2/2014)... (PRWEB) September 02, 2014 Developers and ... announced a new ProIntro Lesson from Pixel Film Studios. ... easy and fresh-looking titles,” said Christina Austin, CEO of ... armature, ProIntro is a definite game changer.” , Learn ... ProIntro Lesson from Pixel Film Studios. ProIntro is a ...
(Date:9/2/2014)... (PRWEB) September 02, 2014 NOVAtime ... Management solution development company, announced today that Avon ... 2009, has upgraded to NOVAtime 4000 Time ... conjunction with NOVAtime’s latest smart clock, the ... Farmington Valley of Connecticut is an award-winning nursing ...
(Date:9/2/2014)... 02, 2014 “Harmonicas have been ... decade, primarily to help people with COPD or ... three developed systems,” says Dana Keller, PhD, co-inventor ... the goals are much the same – improved ... type of harmonica.” , The three approaches to ...
(Date:9/2/2014)... (PRWEB) September 02, 2014 September 2014 – ... long gone. But even though men shave daily – and ... – rough and irritated skin isn’t inevitable, according to ... P.C. , For decades, skin care was something in ... a surge in men of all ages who realize that ...
(Date:9/2/2014)... AURO the enterprise Canadian Public ... expansion of its leadership team with the appointment of ... Liang joins AURO in conjunction with his current role ... with the operations, product management and engineering teams to ... well as ensuring effective internal and external controls are ...
Breaking Medicine News(10 mins):Health News:Pixel Film Studios Released a New ProIntro Lesson Exclusively for Final Cut Pro X 2Health News:Pixel Film Studios Released a New ProIntro Lesson Exclusively for Final Cut Pro X 3Health News:Avon Healthcare Upgrades to NOVAtime 4000 Time and Attendance / Workforce Management Solution with NT7000 Smart Clocks 2Health News:Avon Healthcare Upgrades to NOVAtime 4000 Time and Attendance / Workforce Management Solution with NT7000 Smart Clocks 3Health News:Harmonica Techs, Inventor of the Pulmonica Pulmonary Harmonica, Outlines New Uses for Harmonicas in Healthcare 2Health News:Harmonica Techs, Inventor of the Pulmonica Pulmonary Harmonica, Outlines New Uses for Harmonicas in Healthcare 3Health News:Rough Isn’t Rugged in Men’s Skin: Dermatology specialist Dr. Joshua Fox with Advanced Dermatology PC offers tips on easy skin maintenance for men 2Health News:Rough Isn’t Rugged in Men’s Skin: Dermatology specialist Dr. Joshua Fox with Advanced Dermatology PC offers tips on easy skin maintenance for men 3Health News:AURO Appoints Kevin Liang as New Chief Financial Officer for Canadian Enterprise Public Cloud 2Health News:AURO Appoints Kevin Liang as New Chief Financial Officer for Canadian Enterprise Public Cloud 3
... following Hurricane Katrina, the health of survivors 65 and ... sample of older adults not affected by the disaster, ... Johns Hopkins Bloomberg School of Public Health. The August ... deadliest hurricanes in U.S. history. Hurricane Katrina displaced thousands ...
... This release is available in French . ... study of its kind on preschoolers has demonstrated that ... effective in reducing the severity and duration of asthma ... of clinical research at the Sainte-Justine Hospital Research Center ...
... -- Stern Communications, a public ... its new client www.healthcarebluebook.com . The start-up ... their zip code for healthcare services. Stern Communications ... into strategic communications resources and campaigns aimed at ...
... Jan. 22 Hillenbrand, Inc.,(NYSE: HI ) ... Thursday, Feb. 5, 2009. The full text of the ... site at www.HillenbrandInc.com . , ... simultaneous webcast with,investors and financial analysts that day at ...
... - Engineers at Purdue and Stanford universities have created ... and other cells react to mechanical stresses from heart ... devices are made by injecting a liquid alloy made ... sheets of a plastic polymer, said Babak Ziaie, a ...
... release is available in Spanish . , ... for detecting the presence of Salmonella spp. and ... time than current systems. Unlike others, this project used clinical ... new diagnostic device is effectively a miniature conventional laboratory inside ...
Cached Medicine News:Health News:Decline in health among older adults affected by Hurricane Katrina 2Health News:New treatment reduces severity of asthma attacks in preschoolers 2Health News:Stern Communications Wins and Helps Launch Healthcarebluebook.com 2Health News:New stretchable electrodes created to study stresses on cardiac cells 2Health News:IK4 develops a portable device for detecting Salmonella in under an hour 2
... 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 ...
... 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 ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... 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 ...
Medicine Products: