Breakthrough Device Designation
FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.
Definition
The Breakthrough Devices Program offers more interactive FDA communication, sprint discussions, and prioritized review for devices that provide more effective treatment or diagnosis of serious conditions and meet at least one additional criterion such as no approved alternatives.What this means in practice
Designation does not change the evidentiary standard for clearance or approval but typically shortens timelines and improves alignment. Breakthrough status can also support Medicare reimbursement under the TCET pathway.Examples
- A novel AI-powered diagnostic device for early detection of pancreatic cancer, a condition with limited early detection options, receives Breakthrough Device Designation.
- A new neurostimulation device designed to reduce severe, refractory epileptic seizures, where current treatments are ineffective, is granted Breakthrough Device Designation.
- A minimally invasive surgical tool that significantly reduces recovery time and complications for a life-threatening cardiac condition, compared to existing open-heart surgery, qualifies for the program.
- •One common mistake is assuming that Breakthrough Device Designation lowers the evidentiary standards for marketing authorization, which it does not.
- •Another pitfall is delaying engagement with the FDA until late in device development, missing opportunities for early feedback and program benefits.
- •Misunderstanding the criteria for designation, particularly the "no approved or cleared alternatives" clause, can lead to wasted application efforts.
- •Failing to maintain the breakthrough characteristics throughout the development process can result in loss of designation.
- •Companies sometimes incorrectly believe that breakthrough designation guarantees Medicare reimbursement, rather than merely facilitating a pathway like TCET, which still requires its own application and review.
Frequently asked questions
Cross-references
Used by
Things that build on this term.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsPathway to classify novel low- to moderate-risk devices that lack a predicate.
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
FDA's most stringent device marketing application, required for high-risk Class III devices.
CMS pathway providing time-limited Medicare coverage for FDA-designated Breakthrough Devices.
De Novo & Breakthrough Pathways
· From this learning pathProduct comprised of two or more regulated components - e.g., drug-device, biologic-device.
Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate.
The objective intent of the manufacturer regarding the use of the device.
Formal FDA feedback request prior to a marketing or IDE submission.
Founder & Investor Primer
· From this learning pathAnalysis of whether a product can be sold without infringing third-party IP.
Ledger of all securities issued by a company and who owns them.
Short-term debt that converts into equity at a future financing round.
Investigation of a company before an investment, financing, or acquisition.
Primary references
3 sources- 1
Breakthrough Devices ProgramVerifiedFDAfda.gov
- 2
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
- 3
IMDRF DocumentsVerifiedIMDRFimdrf.org
Inline markers like [1] jump to the matching reference above.