XPRIZE and FDA Partnership Focused on Expediting Market Entry for New Consumer Technologies in the Mobile Health Space
LOS ANGELES, CA--(Marketwired - Sep 4, 2013) - XPRIZE today announced that the U.S. Food and Drug Administration (FDA) will offer regulatory input to teams competing for the Qualcomm Tricorder XPRIZE, a 3.5-year global competition that will award $10 million to teams that develop a consumer-friendly device capable of diagnosing and interpreting a set of 15 health conditions and capturing key vital signs.
"XPRIZE is in a unique position to help incubate the development of a new generation of multi-functional consumer health devices that point toward the future of mobile health," said Mark Winter, Senior Director, Qualcomm Tricorder XPRIZE. "We greatly value the FDA's willingness to work with us and our teams in this unique context, before they need a full commercial review and clearance process."
In addition to assisting teams in preparing for potential FDA review post-competition, the FDA will benefit by learning about new direct-to-consumer diagnostic technology sooner than when it arrives for official review. Specifically, working with the teams participating in the Qualcomm Tricorder XPRIZE provides the FDA with another platform for testing a unique online communication method for interactions with the stakeholders.
The FDA will provide regulatory input to the XPRIZE teams during the course of the competition via a 3-tiered online help desk. The first tier will provide general input on frequently asked questions on FDA regulations, the second will be more specific to the devices under development as part of the competition, and the third, even more specific to the XPRIZE finalists, will include a method for confidential communications between the agency and the teams.
FDA's dedicated online help desk will provide responses on a continuing basis during the competition and will help teams learn what the FDA may require in the future for approval or clearance of their medical device.
"Part of FDA's mission is to promote public health by helping to bring safe and effective medical devices to U.S. patients," said Jeffrey Shuren, M.D., J.D., director of FDA's Center for Devices and Radiological Health. "The FDA is committed to advancing the development of innovative technologies. The input we provide to the Qualcomm Tricorder XPRIZE competitors to meet their future regulatory challenges will help bring these technologies to the U.S. market more quickly. While the winners receive prizes, all the competitors will benefit by having FDA's early input."
Although the medical devices involved in competition have not been reviewed or approved by the FDA for safety and effectiveness, the agency will provide regulatory input to participating teams throughout the competition. The regulatory input given to the competitors does not guarantee future FDA clearance or approval to market their devices in the U.S. However, such regulatory advice given to competitors will help advance the introduction of emerging diagnostic technologies into the U.S. market.
For more information about the Qualcomm Tricorder XPRIZE, please visit http://www.QualcommTricorderXPRIZE.org.
Founded in 1995, XPRIZE, 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. XPRIZE conducts competitions in five Prize Groups: Education; Exploration; Energy & Environment; Global Development; and Life Sciences. Active prizes include the $30 million Google Lunar XPRIZE, the $10 million Qualcomm Tricorder XPRIZE, and the $2.25 million Nokia Sensing XCHALLENGE. For more information, go to www.xprize.org.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
TRICORDER is a trademark of CBS Studios Inc. Used under license.