MEMORANDUM OF UNDERSTANDING
BETWEEN THE X PRIZE FOUNDATION
U.S. FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
The United States Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) and the X Prize Foundation have a shared interest in encouraging the development of innovative health technologies that could benefit the public health. Both FDA and the X Prize Foundation are referred to individually as a “Party” and collectively as the “Parties.” This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote this shared interest.
1. FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (“the Act”) as amended (21 U.S.C. 301). In fulfilling its responsibilities under the Act, FDA among other things, directs its activities toward promoting and protecting the public health by ensuring the safety, efficacy, and security of drugs, biological products, veterinary products, medical devices and radiological products and the safety and security of foods and cosmetics. CDRH is responsible for ensuring the safety and effectiveness of medical devices and the safety of radiation-emitting products. To accomplish its mission, FDA must stay abreast of the latest technological advances and developments in research by communicating with stakeholders about complex scientific and public health issues.
2. Founded in 1995, the X PRIZE Foundation, a 501(c)(3) nonprofit, is the leading organization solving the world’s Grand Challenges by creating and managing large-scale, high-profile, incentivized prize competitions that stimulate investment in research and development worth far more than the prize itself. The organization motivates and inspires brilliant innovators from all disciplines to leverage their intellectual and financial capital for the benefit of humanity. The X PRIZE Foundation conducts competitions in five Prize Groups: Education; Exploration; Energy & Environment; Global Development; and Life Sciences.
FDA and the X Prize Foundation share an interest in advancing the development of innovative diagnostic medical devices through the Tricorder X Prize Challenge.
The Qualcomm Tricorder X PRIZE Challenge is a $10 million global competition to stimulate innovation and integration of precision medical diagnostic technologies capable of providing reliable health assessments directly to health consumers. The Tricorder Challenge is an open competition where individuals or teams can participate under the guidelines established by the Scientific Advisory Board and Judging Panels formulated by X Prize Foundation.
III. Goals of Collaboration:
1. Encourage the integration of technological advances in artificial intelligence, wireless sensing, and molecular diagnostics with medical devices that could benefit health consumers in the US.
2. Increase FDA’s familiarity with novel technologies being developed for direct-to-consumer diagnostic medical devices.
3. Within the competition framework, encourage innovators to enter the medical device market by providing regulatory feedback regarding FDA’s marketing clearance and approval processes.
4. Within the competition framework, provide an online help-desk to develop and test innovative tools for rapidly collaborating and communicating with device innovators.
5. Through FDA’s partnership with XPF, create public awareness about FDA’s efforts to encourage and facilitate the development of new technologies that could benefit public health.
IV. Substance of the Agreement:
1. FDA will provide regulatory feedback to competitors during the course of the competition. The competition structure includes two rounds; a qualifying round where the competitors’ devices will be evaluated based on technological feasibility, and a final round where consumer testing is conducted to evaluate the accuracy, safety, and ease of use of the devices. FDA will provide regulatory input at both stages by: (1) Serving in a Scientific Advisory Capacity; and (2) Establishing an online help desk to provide responses to regulatory questions raised by the competitors throughout the course of the competition. However, regulatory advice given to competitors during the course of the competition does not act to bind FDA with regard to future submissions to the agency.
2. FDA’s role will be limited to providing regulatory feedback to competitors. FDA will neither provide or receive funding for the competition, nor will FDA take part in deciding the winner of the competition.
3. Each Party will establish a principal point of contact to facilitate the actions carried out under this MOU.
4. The Parties will collaborate in areas of mutual interest as part of the Tricorder X Prize Challenge.
5. The Parties may participate in scientific and regulatory discussions regarding submissions to the challenge.
V. General Provisions:
1. This MOU represents the broad outline of the Parties’ intention to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to the availability of resources. This MOU does not affect or supersede any existing or future understandings or arrangements between the Parties and does not affect the ability of the Parties to enter other understandings or arrangements related to this MOU. This MOU does not create binding, enforceable obligations against any Party. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and the X Prize Foundation operate.
2. Data Sharing Guidelines: The Parties may enter into separate Confidential Disclosure Agreements (CDAs) pertaining to certain data and information shared in accordance with this MOU. FDA will not share any confidential commercial information, trade secrets, or personal privacy information with X Prize pursuant to this MOU. Disclosure of such information is restricted by United States federal law. See 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, 21 CFR 20.61 and 20.63.
VI. Liaison Officers:
A. For the X Prize Foundation:
Grant R. Campany
Senior Director and Prize Lead
X Prize Foundation
800 Corporate Pointe, Suite 350
Culver City, CA 90230
B. For the Food and Drug Administration:
Murray Sheldon, M.D.
Associate Director of Technology and Innovation
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Building 66 Room 5438
Silver Spring, MD 20903
Each Party may designate new liaisons at any time by notifying the other Party's administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Parties will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.
VII. Term, Termination, and Modification:
This agreement, when accepted by all participating Parties, will have an effective period of performance from the date of the latest signature until April 31, 2015 and may be modified or terminated by mutual written consent by both Parties or may be terminated by either Party upon a sixty day advance written notice to the other.
APPROVED AND ACCEPTED FOR
X PRIZE FOUNDATION
APPROVED AND ACCEPTED FOR
FOOD AND DRUG ADMINISTRATION
Jeffey Shuen, M.D., J.D
President and Chairman
X PRIZE Foundation
Center for Devices and Radiological Health
|June 15, 2013|
July 12, 2013