Contact Us   |   Print Page   |   Sign In   |   Join
News and Press: Industry News

Breakthrough Devices Program Final Guidance Now Available

Wednesday, December 19, 2018   (0 Comments)
Posted by: Alisha Brown
Share |

Today, the U.S. Food and Drug Administration (FDA) issued a final guidance on the Breakthrough Devices Program. The final guidance outlines program policies, features and the process for manufacturers when pursuing the breakthrough designation.


The Breakthrough Devices Program is one of the FDA’s initiatives that promote patient access to innovative and potentially safer new therapies and diagnostics. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to devices that treat or diagnose a life-threatening or irreversibly debilitating condition. These devices offer new ways to treat or diagnose a disease, have significant advantages over existing treatment alternatives, or provide another public health benefit.


The Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission.

Learn More about the Breakthrough Devices Program

Learn more about the FDA’s initiative to interweave our innovation and device safety priorities in our Medical Device Safety Action Plan.

Stay Engaged

The FDA will host a webinar on Thursday, January 17, 2019, to help clarify the Breakthrough Devices Program final guidance for manufacturers.


Thursday, January 17, 2019 | 1:00PM-2:30PM Eastern Time


No registration required.


To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar. You must dial-in to hear the presentation and ask questions.


U.S. Callers Dial: 1-888-972-9928

Conference Number: PWXW8407567; Passcode: 2664386


International Callers Dial: 1-312-470-0114

Conference Number: PWXW8407567; Passcode: 2664386


To view the slide presentation during the webinar:


We appreciate your feedback on our webinar program. After the webinar, we will provide a link to a short survey about your webinar experience, which should take no more than 5-10 minutes to complete. Your responses are confidential and will be used to help ensure the quality of our webinar program.


If you have questions about this guidance, contact the Division of Industry and Consumer Education.

Creating Value
by delivering business-critical resources & bottom line savings
Building Networks
by connecting Michigan's bio-industry one member at a time
Growing Talent
by creating opportunities that develop people & build organizations
Membership Software Powered by YourMembership  ::  Legal