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Medical device companies will pony up $1 billion under new FDA user fee agreement

by Gus Iversen, Editor in Chief | August 24, 2016
Business Affairs Medical Devices
Device companies are close to cutting a deal with the FDA that will require them to pay nearly $1 billion in fees over five years to help fund critical resources for the federal agency's medical device review program.

On Monday a draft agreement was announced stating that from October 2017 through 2022 the FDA would be authorized to collect $999.5 million in user fees — plus adjustments for inflation. It would be the fourth reauthorization of the medical device user fee agreement (MDUFA), which was originally established in 2002 and has always been aimed at improving the efficiency with which new products are brought to market.

The newly drafted fees are a big increase over the $595 million the industry agreed to pay under the current agreement, set in 2012. That agreement doubled user fees from $295 million over five years in exchange for performance goals set for the FDA.
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"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.

In a joint statement, AdvaMed, MITA and the MDMA praised the tentative agreement, saying it built on the existing one, while also adding metrics to achieve reductions in total review times, as well as 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.

The agreement provides the federal agency with an increase in funding from user fees over the five year period, which the FDA will use 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 to FDA’s device review process, according to the joint statement.

In addition, according to Shuren, the funding will help the agency collect real-world evidence from registries, EHRs, and other digital sources from throughout the device's life cycle. He called MDUFA IV "the result of more than a year of public input and negotiations with industry, laboratory, patient and consumer representatives."

“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 lifesaving 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.

Details of the draft agreement will be published for public comment in the coming weeks, according to the FDA, and the final recommendations are scheduled to be delivered to Congress in January.

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