Comments open on MDUFA IV

It seems like only yesterday that Congress, the FDA, and industry came together to reauthorize the Medical Device User Fee Agreement (MDUFA III).  Now the process begins again as we prepare for MDUFA IV.

MDUFA IVThe Food and Drug Administration Safety and Innovation Act (Public Law 112-144) includes the Medical Device User Fee Amendments of 2012, or MDUFA III. MDUFA III took effect on October 1, 2012 and will sunset in five years on October 1, 2017.

Device user fees were first established by Congress in 2002. Medical device companies pay fees to FDA when they register their establishment and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions.

Ultimately, MDUFA III represents a commitment between the U.S. medical device industry and the FDA to increase the efficiency of regulatory processes in order to reduce the time it takes to bring safe and effective medical devices to the U.S. market.

Booz Allen Hamilton was commissioned to independently evaluate progress and make recommendations. The report,released in June 2015, can be found here:

Independent Assessment of FDA Device Review Process Management Deliverable 10: Final Report on Findings and Recommendations

On  Monday July 13th, a public meeting to discuss the upcoming MDUFA reauthorization (medical device user fee reauthorization) was held.  This public meeting was the first step in what is expected to be a many-months long negotiating process between the medical device industry and FDA.   The FDA has requested community comments  and the window is open until August 12,2015. 


AZBio’s Medical Device Community Members are encouraged to share their insights during the comment period.  The final day to comment is August 12, 2015.

Tips for submitting effective comments

Here is a copy of the comments AZBio has submitted:

July 26, 2015

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852.

Thank you for the opportunity to share our comments on the upcoming Medical Device User Fee (MDUFA) Reauthorization.

The Arizona Bioindustry Association, Inc. (AZBio) is a non-profit industry association representing life science innovators, university and private research institutions, all of Arizona’s major hospital systems, patient advocacy organizations, and supporting for-profit and non-profit partners. Together we are committed to support the discovery, development, commercialization, delivery and availability of life-changing and live-saving innovations that support the sustainability of our people, and our communities.

Arizona’s medical technology industry includes medical device manufacturers working to make life better for patients with metabolic diseases, heart disease, cancer, neurological diseases, challenges to mobility, patients suffering from chronic pain, and more.

With a goal of ensuring that safe and effective medical device innovations become available to patients without unnecessary delay, Congress reauthorized the Food and Drug Administration’s (FDA) authority to collect medical device user fees user fees in July 2012 (PL 112-144, the “Food and Drug Administration Safety and Innovation Act” or FDASIA). This the third authorization of the medical device user fee program (MDUFA III) has proven to be a good one for patients, industry, and the FDA. It is a substantial improvement over the previous medical device user fee agreement and laid the groundwork for significantly improved performance through increased accountability, more meaningful goals, important process improvements, better metrics and additional resources. As the negotiations begin on the next iteration of MDUFA, AZBio supports building on this framework and further strengthening the MDUFA program to improve consistency and predictability in the medical device review program.

Under MDUFA III, FDA performance has improved. FDA decisions for all submission types are meeting performance goals. There is a marked improvement in 510(k) average time to decision goal. While the PMA picture is still somewhat unclear, we are encouraged by these 510(k) improvements. Additionally, part of the MDUFA III user fee agreement involved more detailed reporting of data. This more detailed reporting has led to early identification of potential issues, which industry and FDA have then worked together to address. Lastly, the MDUFA III agreement included increased industry interactions with FDA reviewers, and this has also been a positive experience.

Each MDUFA agreement has brought incremental improvements to both the process and the working relationship between industry and FDA. As we approach the MDUFA IV negotiations, additional improvements will continue the incremental innovation that benefit all stakeholders across the process:

1)Review times, though improved, are still above pre-user fee program levels. We urge FDA to continue to strive for performance improvements to eliminate this discrepancy.
2)Experiences with FDA are reviewer dependent. This variation and the harmful impact it can have on predictability and consistency was highlighted in the 2014 Booz Allen Hamilton “Independent Assessment of FDA Device Review Process Management”


FDA relies on its employees to implement and achieve the results committed to in each user fee agreement. We believe that it is critically important that the resources and recommendations highlighted in this report are seriously considered so that our FDA partners have what they need to ensure that safe and effective med tech innovations become available to patients without unnecessary delay.

Again, thank you for this opportunity to comment on the upcoming MDUFA negotiations. The MDUFA is an important tool for supporting innovation and for ensuring that patients have timely access to safe and effective medical devices.

Joan Koerber-Walker
President and CEO,
Arizona Bioindustry Association, Inc.

Posted in AZBio News, Government Affairs Blog.