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# House Hearing Backs Device User Fee Reauthorization
- URL: https://www.fdaweb.com/house-hearing-backs-device-user-fee-reauthorization/
- Published: 2017-03-28T12:00:00.000Z
- Updated: 2026-09-14T22:14:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138317

House Energy and Commerce Committee lawmakers from both sides of the aisle urged Congress and the Trump Administration 3/28 to reauthorize medical device user fees for another five years before the program expires 9/30\. During a hearing, CDRH director **Jeff Shuren** painted a rosy picture of an improving user fee program that will only get better if the Medical Device User Fee Act (MDUFA 4) is reauthorized.

Shuren’s testimony said that as of 2015, PMA device approvals are averaging 276 days, which is a 35% decrease since the previous MDUFA 3 was enacted. With 510(k) devices, clearances are taking 133 days, an 11% decrease from five years ago. Further, the median time to approve an IDE was 30 days in FY 2015, down from 442 days in 2011 — a 93% decrease in four years. “This improvement has allowed companies to begin their clinical trials earlier so they can begin collecting data to support a decision on their submission requesting marketing authorization,” he said. “In addition, we reduced the average time to reach a decision on a *de novo* classification request, the submission type typically used by novel low or moderate-risk devices, to 259 days in FY 2014, down from 770 days in FY 2009 (a 66% decrease).”

Asked by health subcommittee chairman **Mike Burgess** (R-TX) to discuss culture changes at CDRH that have allowed for these operational improvements, Shuren said the biggest difference is that “we are putting the emphasis on the other side of our mission. For so long we have focused on protecting public health, but we also have to think about promoting public health. It is not just assuring that medical devices are safe and effective, but also that patients have timely access to new devices and that we facilitate device innovation... Being first in the world is really not about beating other countries, but more about timely patient access. We have moved towards more of a flexible benefit-risk paradigm and how we think about technologies, which helps them to market more quickly but appropriately. We are factoring in the perspectives of the patients and what are the values and trade-offs they are willing to make in decisions. And now we are relying more on real world evidence, which can be generated in number of cases in less time and at a lower cost.”

On patient perspectives being incorporated into reviewers’ decision making, Shuren said the Center has “been advancing the science of patient preferences to determine the tools that can be used to quantitatively assess tradeoffs patients are willing to make.” As an example, Shuren described a study on obesity devices that helped determine patient perspectives. He said that from 2007 to 2014 no obesity devices were approved. “When we incorporated patient perspectives, we changed the paradigm and now we have approved six since then, and the pipeline is rich,” he said. A guidance on factors to consider for doing these patient perspective studies has been created, and with MDUFA 4 resources the Center is expected to build a more formal patient engagement program, he added.

Rep. **Gene Green** (D-TX) asked Shuren to explain why a recent MDUFA quarterly report showed that the time to approve PMA devices went up. “One of the contributors might be the success of the review program leading to more innovative and complex technologies coming to the U.S., and it is a good thing,” Shuren responded. MDUFA 4 will provide more resources and build in a quality management system to help CDRH improve its processes, reduce waste and lower costs, and boost program effectiveness, he added.

Rep. **Diana DeGette** (D-CO) asked the director about progress CDRH is making as a participant in the International Medical Device Regulators Forum. Shuren said the group has just started its biggest project yet, which will put the “building blocks together to hopefully establish a medical device single review program where the approval decisions by one participating jurisdiction are relied on in whole or in part by another jurisdiction. That would be one of the most fundamental changes in the medical device arena... Competency training and the conduct of third-party reviews is the first building block... MDUFA 4 also provides greater support for a more robust third-party review program, which will be more important if we are ever to get to the place of a harmonized single review program.”

  
Asked about medical device inspections and why firms are given 15 days to submit a remediation plan when deficiencies are cited, but FDA reviewers have no such timelines to respond to companies on these remediation plans and whether they meet expectations, Shuren said CDRH and the Office of Regulatory Affairs are working on new standard operating procedures (SOPs). “ORA handles the inspections and its Program Alignment effort is being officially stood up in the coming weeks, and as part of that ORA and CDRH will look at SOPs to make device inspections more efficient and more timely and to have the right kind of engagement back with the companies.”