Applicants selected for the Challenge will work directly with the FDA to accelerate the development and eventual review of marketing applications for innovative products, similar to what occurs under the Breakthrough Devices Program. In addition, Breakthrough Device designation will be granted to those devices that meet the statutory criteria for designation without submission of a separate application.
Proposals submitted will be evaluated based on the feasibility, potential public health impact, and novelty of the concept. The number of proposals selected into the Challenge will be determined by the quality of applications received and available FDA resources. The FDA intends to announce applications selected for the Challenge in November 2018.
The criteria for selection, application instructions, and additional information can be found here.
Learn more about the Challenge in a webinar on July 25
- Dial: 888-282-0360; International Callers Dial: 1-630-395-0147; Conference Number: PWXW7562309; Passcode: 2848432
- To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW7562309&p=2848432&t=c
- Following the webinar, a transcript, audio recording, and slides will be available at: https://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.