New Medical Device User Fee Agreement Sets the Stage For Continued Progress in FDA Performance

Latest Deal Builds on Success of MDUFA III


WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed), the Medical Device Manufacturers Association (MDMA), and Medical Imaging & Technology Alliance (MITA) today announced that a tentative agreement has been reached with FDA to reauthorize the Medical Device User Fee Act, building on the progress from the 2012 user fee agreement to further improve the agency’s device review process while maintaining its robust standards for patient safety.

The tentative user fee agreement builds on the 2012 deal which, for the first time, included metrics to achieve reductions in total review times, opportunities for interactions between FDA and application sponsors before and during the review process, and an independent outside review of the agency’s management review process.

Key performance goals of the latest user fee agreement include:

  • Significant improvements for total review time goals, which will lower the total time goal for 510(k)s and PMAs to historical norms.
  • Greater accountability through two independent analyses of FDA’s management of the review process – one at the beginning and one at the end of the MDUFA IV timeline – and implementation by the agency of a quality system management approach to the device review process. FDA’s quarterly and annual reporting requirements have been enhanced as well.
  • Further process enhancements to increase the consistency and timeliness of the review process. These include FDA commitments to provide feedback to companies at least five days prior to a pre-submission meeting; a requirement to document the rationale for issuing a deficiency letter; implementation of a standards conformity assessment program; and a pilot to assess the effectiveness of real-world evidence to support premarket activities.

“This tentative agreement is good news for FDA and industry, and most importantly for patients worldwide,” said Scott Whitaker, AdvaMed president and CEO. “This agreement will allow for continued progress in improving the efficiency and predictability of the agency’s review process, and that means doctors and patients will have more timely access to the innovative tests, treatments and cures they are depending on.”

“It is critical that medical technology innovators are empowered to develop the cures and therapies that improve patient care, and the proposed enhancements in this tentative agreement will help achieve this goal, ” said Mark Leahey, president and CEO of MDMA. “Patients and providers deserve the best of American innovation, and we look forward to working with FDA, Congress and all stakeholders to ensure timely access to safe and effective technologies. ”

“This agreement is a big win for patients, industry and the agency, throughout the course of MDUFA IV. As the medical imaging industry continues to innovate at a fast rate, providing the FDA with the necessary resources to keep pace with life-saving technology through digital health and standards initiatives will ensure that patients have timely access to the most innovative devices and diagnostics necessary for the public health,” said Nelson Mendes, MITA Board chairman, and president and CEO of Ziehm Imaging Inc.

The agreement provides FDA an increase in funding from user fees over five years, which will give FDA the ability to hire additional reviewers, conduct IT and other infrastructure improvements, and enhance training for reviewers. In addition, the new user fee deal includes patient engagement provisions which will allow the patient community greater opportunity to provide feedback into FDA’s device review process.


The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the collective voice of medical imaging equipment, radiation therapy and radiopharmaceutical manufacturers, innovators and product developers. It represents companies whose sales comprise more than 90 percent of the global market for advanced medical imaging technology. For more information, visit Follow MITA on Twitter @MITAToday.

MDMA is a national trade association based in Washington, DC providing educational and advocacy assistance to innovative and entrepreneurial medical technology companies. MDMA’s mission is to promote public health and improve patient care through the advocacy of innovative, research-driven medical device technology. Learn more at

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit


FDA Statement on Medical Device User Fee Agreement

Background: FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations for the fourth reauthorization of a medical device user fee program. Under the new draft agreement, the FDA would be authorized to collect $999.5 million in user fees plus adjustments for inflation over five years starting in October, 2017. This funding would provide critical resources to the FDA medical device review program. Details of the draft agreement will be published for public comment in the coming weeks, and the final recommendations are scheduled to be delivered to Congress in January, 2017.

“MDUFA IV is the result of more than a year of public input and negotiations with industry, laboratory, patient, and consumer representatives,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “This draft agreement represents a substantial investment in the future of the agency’s medical device program and reflects the efforts the FDA has made to meet or exceed its performance goals and to help speed patient access to safe and effective medical devices. This funding will also improve the collection of real world evidence from different sources across the medical device lifecycle, such as registries, electronic health records, and other digital sources.”





Posted in AZBio News.