Navigation Links
FDA Seeks Comment on Proposed Guidelines for High-Quality Clinical Studies
Date:8/15/2011

this guidance is developed primarily for clinical studies used to support PMAs, the recommendations of this guidance may also be used in designing clinical studies used to support 510(k) submissions.

For more information:

CDRH Plan of Action for 510(k) and Science

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

Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff: Design Considerations for Pivotal Clinical Investigations for Medical Devices http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm265553.htm

FDA: Medical Devices

http://www.fda.gov/MedicalDevices/default.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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. Seymour Hospital Seeks to Meet Meaningful Use Requirements With Prognosis ChartAccess® Comprehensive EHR
2. Warner Chilcott Seeks to Refinance its Existing Credit Agreement
3. FDA Seeks to Invest in Foodborne Illness Prevention, Medical Product Safety and Countermeasures
4. The Welcome Back Awards Seeks Nominations to Honor Leaders in the Depression Community
5. Tibotec Pharmaceuticals Seeks European Marketing Authorization for Investigational Once-Daily HIV Treatment TMC278
6. Study Seeks Volunteers to Measure Safety of Treatment Boost for Patients with Oropharyngeal Cancer
7. Abbott Seeks FDA Approval of a New Six-Month 45-mg Formulation of Lupron(R) Depot for the Palliative Treatment of Advanced Prostate Cancer
8. We Keep Moving Project Seeks Stories of People Across the Country Living With and Affected by MS
9. Sigma-Aldrich Announces SAGE(TM) Priority Partners Program; Seeks Researchers to Evaluate New Knockout Rat Models
10. New Legislation Seeks to Boost Participation in Clinical Trials for Rare Diseases
11. Mayo Clinic Seeks New Therapies for Alcoholic Hepatitis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/15/2014)... and BRIDGEWATER, N.J. , ... REGN) and Sanofi US (EURONEXT: SAN and NYSE: SNY) ... organizations to launch Cholesterol Counts , an awareness ... cholesterol, their numbers, and the risks associated with high ... www. CholesterolCounts .com to take a brief ...
(Date:12/15/2014)... Dec. 15, 2014   DaVita HealthCare Partners ... the nation,s largest and most innovative health care ... units, DaVita Clinical Research  (DCR) and  HealthCare Partners ... expand its extensive clinical research and data analytics ... (CKD) and end-stage renal disease (ESRD), as well ...
(Date:12/13/2014)... , December 12, 2014 ... has announced the addition of the  "Global ... Size, Share, Global Trends, Company Profiles, Analysis, ...  report to their offering.       ... tubes made up of medical grade material ...
Breaking Medicine Technology:Have You Been Counted? Regeneron and Sanofi US Join Forces with Leading Cardiovascular Organizations to Raise Awareness of Cholesterol 2Have You Been Counted? Regeneron and Sanofi US Join Forces with Leading Cardiovascular Organizations to Raise Awareness of Cholesterol 3Have You Been Counted? Regeneron and Sanofi US Join Forces with Leading Cardiovascular Organizations to Raise Awareness of Cholesterol 4Have You Been Counted? Regeneron and Sanofi US Join Forces with Leading Cardiovascular Organizations to Raise Awareness of Cholesterol 5Have You Been Counted? Regeneron and Sanofi US Join Forces with Leading Cardiovascular Organizations to Raise Awareness of Cholesterol 6DaVita Clinical Research and HealthCare Partners Clinical Research to Merge and Expand Clinical Trials and Data Analytics Capabilities 2DaVita Clinical Research and HealthCare Partners Clinical Research to Merge and Expand Clinical Trials and Data Analytics Capabilities 3DaVita Clinical Research and HealthCare Partners Clinical Research to Merge and Expand Clinical Trials and Data Analytics Capabilities 4Global Catheters Market (Product Types and Geography) - Forecast to 2020 2Global Catheters Market (Product Types and Geography) - Forecast to 2020 3
... Consumer Healthcare Products Association issued the following ... Management Advisory Committee,s recommendation not to schedule ... "Today,s FDA advisory committee decision  not  to ... as a controlled substance reflects a sound ...
... Jane Staveley, a Principal Environmental Scientist for ARCADIS ... services company, will moderate a distinguished panel of experts ... and Responses" during a briefing in the Rayburn House ... held from noon to 1:30 p.m. and is presented ...
Cached Medicine Technology:Statement from CHPA on Today's FDA Advisory Committee Meeting on Dextromethorphan 2ARCADIS' Jane Staveley to Moderate Congressional Briefing on Pharmaceuticals in Drinking Water 2
(Date:12/17/2014)... -- Expectant parents should leave prenatal picture-taking to medical ... Use of ultrasound imaging and heartbeat monitors to get ... agency warns. "Although there is a lack ... and heartbeat monitors, prudent use of these devices by ... FDA biomedical engineer, said in an agency news release. ...
(Date:12/17/2014)... HealthDay Reporter , TUESDAY, Dec. 16, ... America, and work commitment is a big reason why, new ... said Dr. Mathias Basner, an assistant professor of sleep and ... of Medicine. A time-use survey of nearly 125,000 Americans, ... main activity exchanged for sleep. Short sleepers -- those who ...
(Date:12/15/2014)... 15, 2014 South Florida’s leading urgent care ... can be a daze of hassle, hustle, and bustle that ... decking halls, to burns when making special meals and heartburn ... can happen at any time. To prevent this season of ... made a list of helpful and healthful holiday tips to ...
(Date:12/15/2014)... News) -- Expert pilots process visual information more efficiently ... better decisions during landings, a new study shows. ... pilots to master, and 36 percent of all airplane ... final approach and landing. Researchers monitored the brain ... pilots while they were at the controls of a ...
(Date:12/15/2014)... 15, 2014 At the leading, long-established ... AutismOne and Focus Autism will welcome ... research on the effects of toxins to children’s health, ... information. , Luminaries such as Dr. Lucija Tomljenovic ... with esteemed, credentialed colleagues of the United States to ...
Breaking Medicine News(10 mins):Health News:FDA Warns Against Fetal 'Keepsake' Videos 2Health News:Work Steals Valuable Sleep Time, Study Finds 2Health News:Work Steals Valuable Sleep Time, Study Finds 3Health News:MD Now Urgent Care Presents Healthy Holiday Tips 2Health News:MD Now Urgent Care Presents Healthy Holiday Tips 3Health News:Study Shows Why Expert Pilots Are Experts 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 3
... women could be saved every year, thanks to a simple ... risk of having ovarian cancer at a much earlier stage. ... have developed a new QCancer algorithm using the UK QResearch ... and risk factors to red flag those most likely to ...
... first time estimated the cost and impact of disabilities on the ... with a serious disability in Spain is in a state of ... "With a compared and contrasted methodology, our study shows ... much it can contribute to increasing poverty," explains Francisco Javier Braa ...
... are reporting identification of two substances in licorice used ... bacteria responsible for tooth decay and gum disease, the leading ... study in ACS, Journal of Natural Products , they ... and preventing tooth decay and gum disease. Stefan ...
... are being urged to differentiate between two types of bladder ... analysis revealed significant differences between the main subtypes of the ... bladder cancer cases, published in the January edition of the ... showed a 9% overall decrease between 1973 and 2007. ...
... News) -- Rising levels of a hormone associated with ... risk for developing dementia and Alzheimer,s among women, new ... derived from visceral fat. It is known to play ... lipids, while also carrying certain anti-inflammatory characteristics. So, ...
... incidence of deadly liver cancer is on the rise, but what ... Clinic studies published in the January issue of Mayo Clinic ... hepatocellular carcinoma (HCC), or liver cancer, which has tripled in ... to 12 percent five-year survival rate when detected in later stages. ...
Cached Medicine News:Health News:Simple online tool to aid GPs in early ovarian cancer diagnosis 2Health News:Simple online tool to aid GPs in early ovarian cancer diagnosis 3Health News:The cost of disabilities could reach 77.2 percent of household income 2Health News:The cost of disabilities could reach 77.2 percent of household income 3Health News:Major variation in bladder cancer subtype trends highlights need for focused research 2Health News:Insulin-Linked Hormone May Also Raise Alzheimer's Risk 2Health News:Mayo Clinic studies identify risk factors in rising trend of liver cancer 2
... SurgiFrost is a malleable, single-use cryosurgical ... open-heart surgery. The probe will ablate cardiac ... primary cardiac surgical procedure, such as coronary ... (MV) replacement and/or repair and as part ...
The Medtronic StableMapr catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated...
The Valve Mapper Steerocath-Dx has a unique "peanut" shaped tip. It is designed to conform to the anatomy during mapping procedures. Both 8F/8mm and 8F/6mm tips are available....
... designed for use with our CARTO EP ... catheter houses a Biosense Webster sensor at ... time, exact location points from within the ... The NAVI-STAR electro-anatomical navigation catheter is used ...
Medicine Products: