The FDA and the medical device industry hammered out the principles for the user fees medtech companies pay to have the federal safety watchdog review their products.
The 4th iteration of the Medical Device User Fee & Modernization Act would allow the FDA to collect nearly $1 billion in user fees over 5 years, beginning in October 2017. The last MDUFMA bill, enacted in 2012, doubled user fees from $295 million over 5 years to $595 million, in exchange for performance goals set for the FDA.
“MDUFA IV is the result of more than a year of public input and negotiations with industry, laboratory, patient, and consumer representatives,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, said in prepared remarks. “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.”
Lobbying groups for the medical device industry said the new agreement is the 1st to include metrics aimed at reducing review times, increased interaction with FDA staff before and during reviews and a pair of independent analyses of how the FDA manages the medical device approval process.
The MDUFMA IV agreement also includes a quality system management approach and enhanced quarterly and annual reporting requirements, the groups said. If it goes through, it would also require FDA reviewers to give feedback 5 days before the pre-submission meeting and document the thinking behind rejected applications, among other provisions.
“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, ” Mark Leahey, president & CEO of the Medical Device Manufacturers Assn., said in prepared remarks. “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 tentative agreement is good news for FDA and industry, and most importantly for patients worldwide,” added AdvaMed president & CEO Scott Whitaker. “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.”
“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,” noted Ziehm Imaging president & CEO Nelson Mendes, chairman of the Medical Imaging & Technology Alliance.