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

SILVER SPRING, Md., Feb. 1, 2012 /PRNewswire-USNewswire/ -- The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.

Under a user fee program, industry agrees to pay fees to help fund a portion of the FDA's device review activities while the FDA agrees to overall performance goals such as reviewing a certain percentage of applications within a particular time frame.

The agreement in principle is the result of over a year of negotiations between the FDA and industry. It strikes a careful balance between what industry agreed to pay and what the FDA can accomplish with the amount of funding proposed. It would result in greater accountability, predictability, and transparency through such improvements as a more structured pre-submission process and earlier interactions between FDA and applicants.  With the additional funding, the FDA would be able to hire over 200 full-time equivalent workers by the end of the five-year program. The FDA and industry expect that the agreement in principle would result in a reduction in average total review times.

"I want to commend my staff and representatives from industry for their tireless work and commitment to achieving an agreement in principle on medical device user fees," said FDA Commissioner Margaret A. Hamburg, M.D.  "Reauthorization of this important program is an essential component for advancing medical device innovation."

The industry associations who have reached an agreement 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/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm236902.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

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:6/23/2016)... 2016 Any dentist who has made an implant ... process. Many of them do not even offer this as ... high laboratory costs involved. And those who ARE able to ... a high cost that the majority of today,s patients would ... Parsa Zadeh , founder of Dental Evolutions Inc. and inventor ...
(Date:6/23/2016)... LOS ANGELES , June 23, 2016 /PRNewswire/ ... (NASDAQ: CAPR ), a biotechnology company ... first-in-class therapeutics, today announced that patient enrollment in ... progrEssion in Duchenne) has exceeded 50% of its ... its enrollment in the third quarter of 2016, ...
(Date:6/23/2016)... 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations headquartered in ... America . ... ... ... ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... ... PawPaws brand pet supplements owned by Whole Health Supply is ... of felines. The formula is all-natural and is made from Chinese herbs that have ... Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia Root Extract ...
(Date:6/25/2016)... ... 2016 , ... Experts from the American Institutes for Research ... June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR experts ... planning, healthcare costs and patient and family engagement. , AIR researchers will be ...
(Date:6/25/2016)... Viejo, California (PRWEB) , ... June 25, 2016 , ... ... to fit their specific project," said Christina Austin - CEO of Pixel Film Studios. ... fully customizable and all within Final Cut Pro X . Simply select a ...
(Date:6/25/2016)... , ... June 25, 2016 , ... ... and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a ... area —Johnson is one of the first doctors to perform the treatment. Orthobiologics ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June ... with. The article goes on to state that individuals are now more comfortable seeking ... common operations such as calf and cheek reduction. The Los Angeles area medical group, ...
Breaking Medicine News(10 mins):