Navigation Links
FDA and Industry Reach Agreement in Principle on Medical Device User Fees
Date:2/1/2012

ement in principle with the FDA include the Advanced Medical Technology Association, the Medical Device Manufacturers Association and the Medical Imaging and Technology Alliance.

Congress first established the user fee program 10 years ago with the Medical Device User Fee and Modernization Act of 2002 (MDUFA I), prompted by growing concerns about the capacity and performance of the medical device review program. The five-year program was reauthorized with the Medical Device User Fee Act of 2007 (MDUFA II) and is set to expire on Sept. 30.

MDUFA II authorized FDA to collect user fees for certain medical device applications, for the registration of certain medical device establishments, and for certain other purposes. Small businesses may qualify for a waiver from fees on certain submissions or may qualify for a reduced fee.

In September 2010, prior to beginning negotiations with regulated industry, the FDA held a public meeting on the device user fee program attended by a variety of stakeholders including industry, scientific and academic experts, health care professionals, and representatives from patient and consumer advocacy groups. Stakeholders provided their assessment of the overall performance of the MDUFA program and their opinions about which aspects of the program should be retained, changed, or discontinued in order to further strengthen and improve the program.

Once the final details of the agreement with industry is completed, FDA will develop a package of proposed recommendations and give the public an opportunity to comment before they are submitted to Congress.

The date of the public meeting has yet to be determined.

For more information

MDUFA Meetings
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModerniza
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. Roundtable of Industry Experts to Discuss Impact, Implications of EVMPD Mandate
2. Pharmaceutical Industry Places Newfound Emphasis on Managed Care Organizations
3. Utilizing Marketing Innovations to Engage with Customer Groups that are Key to the Pharmaceutical Industry
4. Berkery Noyes Releases 2011 Pharma & Healthcare Information and Technology Industry Mergers & Acquisitions Report
5. Excellence Services Program Delivers a Road Map to Successfully Guide the Pharmaceutical Industry Through the New Alliance Landscape
6. China Pharmaceutical Equipment Industry Report, 2011-2012
7. Top 200 Biopharmaceuticals Industry Report (Global)
8. Pharmaceutical Industry Confronting Big Challenges, Opportunities in 2012: Leaders to Convene at Groundbreaking Event on February 7-8 in New Jersey
9. Survey of Biomedical Industry CEOs Finds Lack of Investment and Regulatory Environment Threaten Future Growth and Innovation
10. World Glucose Self-Testing Markets - Trends, Product Overviews, Market Drivers & Industry Participants - ReportsnReports
11. Healthcare Market Transformation Must Continue in 2012 for Improved Long-term Health of Industry
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... , Jan. 23, 2015  CytoSorbents Corporation (NASDAQ CM: ... CytoSorb® extracorporeal cytokine adsorber to reduce deadly inflammation ... receipt of $385,642, net of transaction costs, in ... Technology Business Tax Certificate Transfer Program sponsored by ...
(Date:1/23/2015)... BOSTON , January 23, 2015 Heptares ... is delighted to announce that the Malcolm Campbell ... Congreve (Vice President of Chemistry), Fiona Marshall ... (Chief Executive Officer and co-founder) for the seminal contributions to ...
(Date:1/22/2015)... Colo. , Jan. 22, 2015  BiOptix is pleased ... as Vice President of Chemistry and Biochemistry. Scott joins ... Pharmaceuticals, AstraZeneca Pharmaceuticals, and Amgen throughout the course of ... development. "Scott is a nationally recognized thought ...
Breaking Medicine Technology:CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 2CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 3Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 2Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 3Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 4BiOptix Expands Leadership Team with the Appointment of Dr. Scott Klakamp as Vice President of Chemistry and Biochemistry 2
... NeurogesX, Inc. (Nasdaq: NGSX ), a biopharmaceutical ... announced that it has entered into a $20 million ... HTGC).  The loan agreement includes both a $5 million ... term loan. Proceeds are expected to be ...
... Aug. 8, 2011 Global Health Ventures Inc. ... on sublingual drug delivery announced today that their August ... and CEO, is available for on-demand viewing. ... watch event now" button. Their presentation will ...
Cached Medicine Technology:NeurogesX, Inc. Secures $20 Million Debt Facility 2NeurogesX, Inc. Secures $20 Million Debt Facility 3NeurogesX, Inc. Secures $20 Million Debt Facility 4Global Health Ventures August 4th Investor Presentation Now Available for On-demand Viewing at RetailInvestorConferences.com 2
(Date:1/22/2015)... Recently, Weddingshe.com has added many trendy Champagne ... highest annual revenues in the past three years. Today, the ... dresses. , According to the sales manager of the company, ... them in 2015. This point can be reflected on the ...
(Date:1/22/2015)... Payday lending practices in four southern states ... distress to the states that permit them, according to ... on Race and Wealth. , While they generate hundreds ... at the same time substantially depress economic activity, according ...
(Date:1/22/2015)... JJsHouse.com is a famous dress online store for ... its latest collection of wedding dresses , and launches ... is the wedding dress on your big day; the wedding ... Every bride wants to find the most suitable wedding dress. ...
(Date:1/22/2015)... Step into a macabre world where plants ... Virginia. Wicked Plants, the Museum’s latest featured exhibition, opens ... carnivorous and diabolical plants inside of a dilapidated, Victorian ... biochemical, physical and neurological processes between botanicals and the ...
(Date:12/26/2014)... It is said that nothing makes a lady feel ... wedding dress supplier, shows its new selection of navy ... , UWDress.com’s navy cocktail gowns are the cornerstones of ... fashion styles. Simple dresses in bright neon colors can be ...
Breaking Medicine News(10 mins):Health 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 2Health News:Wicked Plants are taking over the Science Museum of Virginia 2Health News:UWDress.com Shows Its New Navy Cocktail Dresses For 2015 2
... and Industry Thought Leader Joins Healthcare ... Management Consulting Practice, ... to announce the appointment of Ogan Gurel, M.D. as a ... have Dr. Gurel join our team," said Vip Jain - ...
... BET Networks, national HIV/AIDS,public awareness initiative Rap-It-Up returns ... health forums throughout New York City and Newark,N.J., to ... young adults; as well as the rise of HIV/AIDS ... organization Hip,Hop 4 Life and local radio station Hot ...
... to succeed in reducing prevalance of obesity,among children ... intervention and,education, MEMPHIS, Tenn., Nov. 7 ... at St. Jude Children,s,Research Hospital is the first ... in reducing the prevalence of overweight children, according ...
... businesses for its commitment to building a culture of ... ... The American Heart Association,recently recognized Regence as a Start! ... in the workplace and helping,employees live healthier lives. The company ...
... Million ... Million, SUNNYVALE, Calif., Nov. 7 Accuray,Incorporated (Nasdaq: ... announced financial results for the first quarter of fiscal 2008,ended ... 2008, Accuray reported record total,revenue of $48.6 million, up 48 ...
... ... Exploration Process, GERMANTOWN, Md., Nov. ... company focused on,developing and commercializing novel anti-infective products, announced an,agreement ... Company,s largest equity shareholders, raising up to $10 million in,cash. ...
Cached Medicine News:Health News:XRoads Solutions Group Appoints Dr. Ogan Gurel as Managing Director 2Health News:BET Networks' Award-Winning Rap-It-Up HIV/AIDS Campaign Returns to New York City for The Youth Empowerment Tour on November 13-16 2Health News:BET Networks' Award-Winning Rap-It-Up HIV/AIDS Campaign Returns to New York City for The Youth Empowerment Tour on November 13-16 3Health News:St. Jude Program Reduces Weight Gain in Young African-American Girls 2Health News:St. Jude Program Reduces Weight Gain in Young African-American Girls 3Health News:American Heart Association Award Recognizes Regence as a Start! Fit-Friendly Company 2Health News:American Heart Association Award Recognizes Regence as a Start! Fit-Friendly Company 3Health News:Accuray Reports Record Revenue in First Quarter of Fiscal 2008 2Health News:Accuray Reports Record Revenue in First Quarter of Fiscal 2008 3Health News:Accuray Reports Record Revenue in First Quarter of Fiscal 2008 4Health News:Accuray Reports Record Revenue in First Quarter of Fiscal 2008 5Health News:Accuray Reports Record Revenue in First Quarter of Fiscal 2008 6Health News:Accuray Reports Record Revenue in First Quarter of Fiscal 2008 7Health News:Accuray Reports Record Revenue in First Quarter of Fiscal 2008 8Health News:MiddleBrook Pharmaceuticals Raises Up to $10 Million from Deerfield Management 2Health News:MiddleBrook Pharmaceuticals Raises Up to $10 Million from Deerfield Management 3Health News:MiddleBrook Pharmaceuticals Raises Up to $10 Million from Deerfield Management 4Health News:MiddleBrook Pharmaceuticals Raises Up to $10 Million from Deerfield Management 5
... Bio-Quant S. typhi rapid test is ... The test employs a conation of ... polyclonal antibody immobilized on the solid ... typhi,antigen associated Salmonella typhi (typhoid) infection ...
... Mono is an immunochromatographic in vitro ... with,infectious mononucleosis infection.,Infectious mononucleosis (IM) is ... of IM is based on detection ... such as the,heterophile antibodies present in ...
OneStep Midstream Urine hCG Pregnancy InstaTest is a test kit for the determination of hCG(Human Chorionic Gonadotropin) in urine specimens. This test kit is used to obtain a visual, qualitative resu...
... Myoglobin Insta Test is an ... test. It is designed for ... serum specimens. The presence of ... ng/mL or higher can be ...
Medicine Products: