> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Shuren, Industry Support MDUFA 5 at Hearing
- URL: https://www.fdaweb.com/shuren-industry-support-mdufa-5-at-hearing/
- Published: 2022-03-30T12:00:00.000Z
- Updated: 2026-09-14T17:38:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151488

Medical Device User Fee Act (MDUFA) investments made since 2002 have “paid off dividends with an increasing number of device innovators bringing their devices to the U.S. first, and a more robust pipeline of innovative new devices, which ultimately has led to more timely patient access,” CDRH director **Jeff Shuren** told a House Energy and Commerce Committee Health Subcommittee hearing on the MDUFA 5 reauthorization. Shuren apologized for the latest agreement with industry being delayed ([see earlier story](https://www.fdaweb.com/device-user-fee-negotiations-at-standstill/)), but said the long deliberations on the reauthorization will pay off if the reauthorization is enacted by continuing to advance medical device innovation while maintaining FDA standards to protect patients.

While the MDUFA 4 five-year period started off strong with FDA meeting or exceeding its performance goals, Covid-19 pandemic-related work beginning in 2020 took its toll on CDRH resources and a lot of the workload was not funded through user fees, he told the hearing. For example, he said that so far during MDUFA 4 FDA has received over 3,000 more pre-submissions than the previous MDUFA 3 period, including more than 1,000 in 2020\. And since fiscal year 2018, FDA has granted more than 600 breakthrough device designations, with more than 200 in the last fiscal year alone. “Medical devices have and continue to be increasingly more complex, and the review of their premarket submissions more resource intensive while the number of submissions we receive annually has increased as well, and we expect these trends to continue,” he said.

During Covid, Shuren said CDRH received about 8,000 emergency use authorization (EUA) and pre-EUA requests, and it granted over 2,200 of these, and it is still receiving about 130 EUA submissions each month. EUA activities are not under the user fee program, and inevitably the strain on resources led to a backlog and delayed review times and CDRH fell short on some of its performance goals.

Through Congress-approved supplemental funding, more staff have been hired and many changes in policy, procedures and practice have seen the Center “turn the corner,” Shuren continued. “CDRH has reduced the backlog of non-Covid device submissions by 44%, and we’re targeting to have most of the Center back to normal operations later this year.” 

Shuren told the subcommittee that MDUFA 5 will take important steps to address resource gaps that began to show before Covid-19, which will support improved performance. “It also features a new accountability mechanism for add on payments, under which FDA would receive additional user fees, if it meets specified goals, Shuren said. “These additional funds come with even more ambitious goals for the later years in MDUFA 5\. The agreement includes a new voluntary pilot to provide earlier more frequent and more strategic engagement with sponsors of breakthrough devices and those included in the Safer Technologies Program, incorporating lessons learned from the pandemic, where we saw how engaging with sponsors through the pre EUA process to problem solve and answer their questions in real or near real time, which is critical to facilitating important technologies coming to market quickly and safely.”

Additionally, the MDUFA 5 proposal would “support advancement of the patient perspective and regulatory decisions, continued expansion of the use of national and international consensus standards, leveraging real-world evidence regulatory decision making, and enhanced coordination with international regulators to advance global harmonization, among other priorities,” Shuren told the hearing.

Advanced Medical Technology Association (AdvaMed) senior executive vice president **Janet Trunzo** testified that her members believe the new user fee agreement will “further strengthen the medical device premarket review program by ensuring the agency has the resources it needs, enhancing review predictability, consistency and performance, and by continuing to ensure patients have timely access to safe and effective devices.”

She said that under MDUFA 5, AdvaMed expects to see improvements in review times compared to MDUFA 4 goals or compared to current performance, depending on the particular submission type. It also provides significant additional resources to ensure that FDA can provide “timely feedback to companies seeking pre-submission guidance from the agency,” she said, adding that this is important because it improves the likelihood that an application will provide the data and information FDA needs to undertake an efficient review of the product and make a timely decision.

Trunzo also noted that her group is encouraged by another pre-submission feedback pilot called the Total Product Lifecycle Advisory Program, which is designed to provide early feedback primarily to breakthrough device makers. Additionally, MDUFA 5 contains specific performance measures to evaluate the program “as a whole by funding a quality management program and two independent assessments of aspects of the program…,” she said. It will also provide additional funding to hire a minimum of 273 new FTEs to support the process for device review, with the potential of up to 387 FTEs based on meeting the enhanced goal targets.