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 receipt
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 |