News & Press: Latest News

MDMA Statement on Tentative User Fee Agreement

Friday, August 26, 2016  
Share |

MDMA Statement on Tentative User Fee Agreement

WASHINGTON, DC – The Medical Device Manufacturers Association’s (MDMA) President and CEO Mark Leahey issued the following statement today regarding the release of meeting minutes for the reauthorization of the Medical Device User Fee Act (MDUFA): 

“This tentative agreement represents an important step to improve patient access to safe and effective products.   Medical technologies serve as a powerful example of what American ingenuity can accomplish when a predictable and reasonable regulatory system is in place.  

“The provisions set forth in this agreement will empower the input of patient communities, help ensure that regulators are asking the right questions at the right time, and strengthen the premarket review process with numerous process enhancements.  MDMA will continue to work with all stakeholders so that the possibilities contained in this proposal are realized, and that America’s med tech ecosystem remains the gold standard for safety and efficacy.” 

The tentative user fee agreement contains numerous targeted investments designed to further streamline the regulatory pathways including: 

  • Significant process improvements that will provide more clarity, specificity, supervisory oversight and routine quality audits;
  • Performance goals for De Novo submissions for the first time, with FDA committing to reach a decision on 70% of submissions by 150 Days by the end of FY22;
  • Performance goals for per-submissions for the first time, with FDA committing to provide meaningful written feedback to innovators at least five days prior to a scheduled pre-submission meeting and having the meetings within 70 FDA days;
  • Improved average total time to decision to 108 days for 510(k)s and to 290 days for PMAs by the end of FY2022;
  • Enhanced patient engagement and patient input by levering public private partnership and building internal capabilities;
  • A pilot to establish the value of real world evidence (RWE) and linkages among data sources to enable greater use of RWE to accelerate patient access in the premarket setting; and
  • Expansion of the Independent Assessment to complete the MDUFA III review and assess MDUFA IV reforms.