login
Password reminder
Cardiac Rhythm News
Contact the editor Visit Cardiac Rhythm News Twitter feed Visit Cardiac Rhythm News Facebook page
 

FDA and industry reach agreement in principle on medical device user fees


Tuesday, 21 Feb 2012 16:14

The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorisation of a medical device user fee programme.


The recommendations would authorise the FDA to collect US$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 finalised soon.


Under a user fee programme, 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 programme. 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. “Reauthorisation of this important programme 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 programme 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 programme. The five-year programme was reauthorised with the Medical Device User Fee Act of 2007 (MDUFA II) and is set to expire on 30 September.


MDUFA II authorised 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 programme 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 programme and their opinions about which aspects of the programme should be retained, changed, or discontinued in order to further strengthen and improve the programme.


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.




Add New Comment

Most popular


“We all need the strength” to challenge unacceptable behaviour
Thursday, 20 Aug 2015
The editors of Annals of Internal Medicine have called for doctors to confront colleagues who act in a disrespectful manner towards patients after an anonymous essay in the journal highlighted ... “We all need the strength” to challenge unacceptable behaviour

New stem cell delivery method shows promise for treating end stage heart failure
Monday, 27 Jul 2015
A new clinical trial to test how a high dose of stem cells delivered via a method called retrograde coronary sinus infusion affects end stage heart failure patients is showing promising results. New stem cell delivery method shows promise for treating end stage heart failure

First participants enrolled in dabigatran study of AF patients undergoing PCI
Wednesday, 29 Jul 2015
Boehringer Ingelheim has announced that the first US patients have been enrolled in its international clinical trial—RE-DUAL PCI, which is evaluating the efficacy and safety of dabigatran in patients ... First participants enrolled in dabigatran study of AF patients undergoing PCI

Features


New trial to explore oral anticoagulation benefit in patients with atrial high rate episodes
Monday, 03 Aug 2015
AFNET and the ESC are initiating a new trial (NOAH – AFNET 6) investigating whether patients without diagnosed atrial fibrillation who present with atrial high rate episodes benefit from oral ... New trial to explore oral anticoagulation benefit in patients with atrial high rate episodes

Safety, accuracy and validation of medical smartphone applications
Tuesday, 28 Jul 2015
The use of mobile smartphones and tablets that run applications (apps) to function as clinical examination tools, reference databases, technique guides, or medical calculators is today a reality in ... Safety, accuracy and validation of medical smartphone applications

Profiles


Cecilia Linde
Monday, 22 Jun 2015
Cecilia Linde speaks to Cardiac Rhythm News about her work on a research platform for new onset ... Cecilia Linde

Michael Gold
Wednesday, 03 Jun 2015
William Gold spoke to Cardiac Rhythm News about his involvement in various clinical trials, his ... Michael Gold

Cardiac Rhythm News Vascular News Cardiovascular News Interventional News Spinal News NeuroNews
BIBA Medical BIBA MedTech Insights CX Symposium ilegx
Password Reminder

BIBA Medical, 526 Fulham Road, Fulham, London, SW6 5NR.
TEL: +44 (0)20 7736 8788 FAX: +44 (0)20 7736 8283 EMAIL: 
info@bibamedical.com
© BIBA Medical Ltd is a company registered in England and Wales with company number 2944429.
VAT registration number 730 6811 50.
Site Map | Terms and Conditions