FDA Reaches Agreement with Industry for Reauthorization of Medical Device User Fees

| Printer friendly version

The Food and Drug Administration has issued a statement announcing that the FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations for the fourth reauthorization of the medical device user fee program (MDUFA IV).

Under the new draft agreement (to be published in the coming weeks), the FDA would be authorized to collect almost $1 billion in user fees over five years starting in October 2017.  This funding would provide critical resources to the FDA medical device review program.

The director of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, M.D., has commented:

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.

First established in 2002 to provide the FDA with the resources necessary to better review medical devices, device user fees have helped the FDA increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market.  These fees, which range from the thousands to hundreds of thousands depending on the type of review required, are paid by medical device companies when they register their establishments and list their devices with the agency or submit an application or a notification to market a new medical device in the U.S.

The current legislative authority for the medical device user fee program expires on October 1, 2017, and new legislation will be required for the FDA to continue collecting user fees for the medical device program in future fiscal years.

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.

Chang Lim
Chang Lim practices intellectual property law, with a focus on patent counseling and protection of innovations in the electronics, software, and healthcare industries. He represents clients in matters involving a diverse range of technologies including video coding, cloud computing, user interfaces, consumer electronics, data protection, and surgical robotics.
Click here to read full bio
View all posts published by Chang Lim »

Leave a Reply

By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.