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August 23, 2016

FDA and Industry Groups Announce Tentative Accord to Reauthorize Medical Device User Fee Agreement

August 24, 2016—The US Food and Drug Administration (FDA) announced that it has reached an agreement in principle with representatives from the medical device industry and laboratory community on proposed recommendations for the fourth reauthorization of a medical device user fee program. Under the new draft of the Medical Device User Fee Agreement (MDUFA IV), the FDA would be authorized to collect $999.5 million in user fees plus adjustments for inflation over 5 years starting in October 2017. 

According to the FDA, this funding would provide critical resources to the agency’s 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.

Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, commented in the announcement, “MDUFA IV is the result of more than a year of public input and negotiations with industry, laboratory, patient, and consumer representatives. 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.”

In a joint announcement, the Advanced Medical Technology Association (AdvaMed), the Medical Device Manufacturers Association, and the Medical Imaging & Technology Alliance stated that the tentative agreement builds 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 2012 deal included, for the first time, 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.

According to the industry groups, the latest user fee agreement includes the following key performance goals:

  • Significant improvements for total review time goals, which will lower the total time goal for 510(k) clearances and premarket approvals to historical norms.
  • Greater accountability through two independent analyses of the 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. The 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 5 days before a presubmission 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.

In the announcement, AdvaMed President and CEO Scott Whitaker stated, “This tentative agreement is good news for the FDA and industry, and most importantly for patients worldwide. 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.”

The industry representatives also noted that the increased funding from user fees over 5 years will give the FDA the ability to hire additional reviewers, conduct information technology 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 the FDA’s device review process.

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August 24, 2016

English Study Finds Women Have Increased Mortality and Morbidity After AAA Repair

August 24, 2016

English Study Finds Women Have Increased Mortality and Morbidity After AAA Repair