Section 515B, FD&C Act · Breakthrough Devices Program
Under Section 515B of the FD&C Act, Breakthrough Device designation requires a device to meet Criterion 1, more effective treatment or diagnosis of a life threatening or irreversibly debilitating condition, plus at least one of four Criterion 2 pathways. Criterion 1 is the one cardiovascular applicants most often fail to support with adequate evidence. Designation is a review pathway benefit, not an approval.
The Statute
Breakthrough Device designation has exactly two requirements. A device must meet Criterion 1, and it must meet at least one of the four Criterion 2 tests. FDA's own language on Criterion 1 is direct.
"The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions."
FDA, Breakthrough Devices Program, Criterion 1. Read the FDA page →Criterion 2 requires at least one of four further showings: the device represents breakthrough technology, no approved or cleared alternative exists, the device offers a significant advantage over existing approved or cleared alternatives, or device availability is in the best interest of patients. For a cardiovascular device, the life threatening or irreversibly debilitating standard in Criterion 1 is usually easy to state in the abstract and hard to tie to the specific device's intended use with real evidence, which is why Criterion 1, not Criterion 2, is the more common point of failure.
Designation is a review pathway benefit: priority review, more frequent interaction with FDA, and a senior reviewer assigned to the submission. It is not a finding that the device is safe or effective, and it does not change the evidence standard the eventual 510(k), De Novo, or PMA submission must meet.
The Standard
FDA's guidance asks whether the available information creates a reasonable expectation that the device will provide more effective treatment or diagnosis, not whether that effect has already been proven in a pivotal study. At the designation stage, the agency expects a credible, device specific case built from the evidence available at that point in development, not confirmatory clinical data the device has not yet generated. What moves a request from plausible to credible is specificity: a stated mechanism, a defined patient population, and a named comparator, not a general statement that the condition is serious.
What Supports It
Across cardiovascular Breakthrough requests, four generic categories of evidence tend to carry a Criterion 1 case. None of these require company specific or product specific detail to describe.
What Goes Wrong
The Submission
A Breakthrough Device request is filed as a Q Submission. The sections that carry the weight of the Criterion 1 case are the device description and intended use, the summary of supporting evidence organized by the four categories above, and the comparison to current treatment or diagnosis. A request padded with background information but thin on the specific evidence tying the device to Criterion 1 is the most common reason FDA asks for a supplemental submission before ruling on designation.
After Designation
Designation changes the process: priority review, an assigned senior reviewer, more frequent and more substantive interaction with FDA during development, and eligibility for certain expedited data development programs. It does not change the evidence the eventual IDE, 510(k), De Novo, or PMA submission must contain, and it does not shorten the clinical program itself if the device genuinely needs a particular study design to demonstrate safety and effectiveness. Designation is a faster, more collaborative path to the same evidentiary bar, not a lower one.
For Non US Applicants
A non US device company requests Breakthrough Device designation itself, directly with FDA; designation is not contingent on where the sponsor is based. A separate requirement appears only if the path to designation runs through a US IDE study, since a company outside the United States cannot itself sponsor an FDA IDE study under 21 CFR 812.18(a).
Common Questions
Criterion 1 requires the device to provide for more effective treatment or diagnosis of a life threatening or irreversibly debilitating disease or condition. Criterion 2 requires the device to meet at least one of four further tests: breakthrough technology, no approved or cleared alternative, significant advantage over existing alternatives, or device availability being in the best interest of patients.
No. FDA states that a Breakthrough Device must still meet FDA's standards for device safety and effectiveness to be authorized for marketing. Designation changes how FDA engages with the sponsor during review; it does not change the evidence standard the eventual submission must meet.
Yes. Breakthrough Device designation is requested by the device sponsor of the eventual marketing submission, regardless of the sponsor's home country. A non US company requests designation itself; a separate US sponsor of record is only required if the path to designation runs through a US IDE study first.
Reviewed October 19, 2026 by ADB's regulatory team.
Related Reading
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