The U.S. Food and Drug Administration is offering regulatory input to teams competing in the $10 million Qualcomm Tricorder XPRIZE, a global competition to develop a consumer-friendly device capable of diagnosing and interpreting a set of 15 health conditions and capturing key vital signs. The FDA's role was announced by XPRIZE, the organizer of the competition.
"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, in a written statement. "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."
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 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 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," according to the announcement, which is quick to point out that the "regulatory input given to the competitors does not guarantee future FDA clearance or approval to market their devices in the U.S."
Currently, there are more than 300 teams from around the world competing. Mark Winter, Senior Director of the Qualcomm Tricorder XPRIZE, in a written statement thanked the FDA for its "willingness to work with us and our teams in this unique context, before they need a full commercial review and clearance process."
The FDA's draft guidance for mobile medical applications was issued in July 2011. However, the FDA has come under fire from critics, including Congress, for being slow to finalize the agency's draft guidance. Critics charge that the draft FDA guidance on mobile medical apps remains unclear and unpredictable.
Without clear guidance, app developers say they don't know whether they should pursue certification of their products as medical devices, sidestep the process altogether and jump into product development or wait for the FDA to issue its final guidance, which is expected by the end of this month.
To learn more:
- read the announcement