The FDA and reps from the medical device industry have settled on a draft agreement that would see devicemakers paying the agency $999.5 million in user fees over 5 years, starting in October 2017.
The draft agreement, announced earlier this week, would be the fourth reauthorization of the Medical Device User Fee and Modernization Act. Initially passed in 2002, with the goal of improving the FDA’s review process for medical devices. It was most recently reauthorized in 2012 for $595 million, in an agreement that, for the first time, included metrics for cutting total review times and an independent outside review of the agency’s review process.
“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,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement.
The increase in funding will enable the FDA to hire and train reviewers and make other improvements to its existing device review processes. Additionally, it will boost the agency’s collection of real-world evidence from various sources, including registries, electronic health records and other digital sources, Shuren said. Other key components of the draft agreement include two independent analyses of the FDA's process, one at the beginning and one at the end of MDUFA IV, and process enhancements, such as a requirement to provide companies with the rationale behind a deficiency letter and FDA commitment to relay feedback to devicemakers at least 5 days before a presubmission meeting, according to a joint statement from MITA, Advamed and MDMA.
“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,” the agency said in a statement.
“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, Ziehm Imaging CEO and MITA chairman in the joint statement.