Breakthrough Device Designation
The Breakthrough Device Designation programme was established by the 21st Century Cures Act (2016) under FD&C Act § 515B [21 U.S.C. § 360e-3]. It is one of FDA's most significant tools for facilitating the development and review of innovative devices for serious conditions.
Eligibility criteria
A device qualifies for Breakthrough Designation if it meets both of the following:
Criterion 1 — Serious or life-threatening condition The device is intended to diagnose or treat a disease or condition that is life-threatening or irreversibly debilitating.
Criterion 2 — Significant advantage The device must meet at least one of the following:
- Represents more effective treatment or diagnosis relative to currently available alternatives
- There is no approved or cleared alternative for diagnosing or treating the disease or condition
- Represents a breakthrough technology that substantially improves patient-important outcomes
- Provides comparable or greater effectiveness with substantially reduced burden (e.g., less invasive, patient-administered)
How to apply
- Submit a Breakthrough Device Designation Request to CDRH's Office of Device Evaluation (ODE)
- Can be submitted at any time during device development — early submission is encouraged
- Request should include:
- Device description and intended use
- Proposed indications for use
- Basis for the claim that the device meets the criteria (disease seriousness, advantage over alternatives)
- Available data supporting the preliminary evidence of effectiveness
FDA response time: 60 calendar days from FDA aims to respond to complete submissions within receipt, though complex requests may require additional time for clarification.
Benefits of designation
Breakthrough Designation does not lower the regulatory standard — the device must still satisfy the applicable 510(k), De Novo, or PMA criteria. However, designation provides:
| Benefit | Description |
|---|---|
| Priority review | Submission receives expedited FDA review |
| Early collaboration | More frequent and interactive communication with FDA during development and review |
| Organisational commitment | Senior FDA management assigned to the device |
| Cross-center coordination | For combination products, facilitates coordinated review across CDRH, CDER, CBER |
| Pre-submission meeting priority | Q-Subs for Breakthrough devices receive priority scheduling |
Breakthrough vs other expedited programmes
| Programme | For | Key difference |
|---|---|---|
| Breakthrough Device | Class II/III devices for serious conditions | Full FDA interaction; no lower standard |
| HDE | Devices for ≤8,000 patients/year | Lower effectiveness standard (probable benefit) |
| STeP | Unmet needs, not meeting Breakthrough criteria | Priority interaction; no MDUFA TTD commitment |
| EUA | Devices during public health emergencies | Emergency use; not a permanent marketing pathway |