On August 22, FDA and representatives from the medical device industry and laboratory community announced 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.
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
- 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 enhancementsto 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.
Industry Response
The Advanced Medical Technology Association (AdvaMed) praised several process improvements included in the agreement, stressing they would lead to greater efficiency, consistency and accountability in the agency’s device review process.
Key among the process improvements in the agreement is a new goal under which FDA commits to providing meaningful written feedback to companies at least five days prior to a scheduled pre-submission meeting. The agency also will update its guidance on the pre-submission process. In addition, for the first time, FDA will be required to document the scientific rationale for issuing a deficiency letter to a sponsor.
The agreement will increase patient input into the regulatory process by leveraging public-private partnerships and allowing for the voluntary use of publicly available and validated Patient Preference Information (PPI) or Patient Reported Outcomes (PRO) in device regulatory submissions. In addition, user fee funds will be dedicated to developing expertise within FDA’s device center to respond to submissions with PPI and PRO information.
“Industry strongly supports the expanded input and involvement the patient community will have in the device regulatory process under this agreement,” said Scott Whitaker, AdvaMed president and CEO. “Properly validated PPI and PRO information can play an enormous role in fostering medical technology innovation and improving patient care.”
“Likewise, we believe there is great potential in the use of real-world evidence to improve patient care, but it is important to ensure that any such data is valid and accurate. We look forward to the results of the pilot program to assess the potential of these additional data sources.”
“This agreement is a big win for patients, industry and the agency, throughout the course of MDUFA IV,” said Medical Imaging & Technology Alliance (MITA) board chairman Nelson Mendes, who is also president and CEO of Ziehm Imaging in Orlando. “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.”
FDA Supportive
“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.”