Do you have a medical device that treats or diagnoses a life-threatening disease? If yes, your device may be eligible for an expedited review pathway called the Breakthrough Devices Program. The FDA defines a breakthrough device as any device (or device-led combination product) that will “provide for more effective treatment or diagnosis of life-threatening or irreversibility debilitating diseases or conditions”...

1. Breakthrough Devices
By: Madison Wheeler
Do you have a medical device that treats or diagnoses a life-threatening disease? If yes, your
device may be eligible for an expedited review pathway called the Breakthrough Devices
Program. The FDA defines a breakthrough device as any device (or device-led combination
product) that will “provide for more effective treatment or diagnosis of life-threatening or
irreversibility debilitating diseases or conditions.”1 This voluntary program was developed by the
FDA as a way to expedite the development, assessment, and review of these devices in order to
get them on the market and to patients who need them much quicker. If your device goes through
the Breakthrough Devices Program, you can expect prioritized review of your submission and
more timely communication from the FDA, since the goal is to get life-saving devices on the
market and available for health care use.
While an expedited FDA review pathway sounds like a dream come true, there are strict criteria
for device eligibility that you must meet first. For any device that is subject to PMA’s, 510(k)’s,
or requests for De Novo the following criteria must be met in full in order to receive
Breakthrough Device Designation:
1. The device provides for more effective treatment or diagnosis of life-threatening or
irreversibly debilitating human diseases or conditions.
2. The device also meets at least one of the following:
a. Represents breakthrough technology
b. No approved or cleared alternatives exist
c. Offers significant advantages over existing approved or cleared alternatives
d. Device availability is in the best interest of patients2
If your device meets these criteria, you can request a Breakthrough Designation at any time prior
to sending the FDA your PMA, 510(k), or De Novo request.
1 FDA (May 2019) Breakthrough Devices Program retrieved on 11/10/2019 from: https://www.fda.gov/medical-
devices/how-study-and-market-your-device/breakthrough-devices-program
2 FDA (December 2018) Breakthrough Devices Program GuidanceDocument retrieved on 11/10/2019 from:
https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

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The Breakthrough Device Program is arguably the least popular device pathway offered by the
FDA; however, the Agency plans to continue to modify the program and get life-saving devices
on the market quicker. At the end of 2018, it was reported in a statement from the former FDA
Commissioner Scott Gottlieb that since the inception of the program was authorized in 2016
“…110 devices have received a Breakthrough Device designation and eight have received
marketing authorization”.3
Do you think your device may qualify for Breakthrough Device designation? EMMA
International can help with your regulatory submission. Call us at (248) 987-4497 or email
info@emmainternational.com to see how we can assist!
3 Gottlieb, M.D. (December 2018) FDA Statement retrieved on 11/11/2019 from: https://www.fda.gov/news-
events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-jeff-shuren-md-director-center-
devices-and-0