FDA Updates Breakthrough Devices Program Information and 2026 Designation Data
The U.S. Food and Drug Administration, FDA, has updated information on its Breakthrough Devices Program, a voluntary program for certain medical devices and device-led combination products.
The program is intended for devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Purpose of the Program
The Breakthrough Devices Program is designed to provide patients and healthcare providers with timely access to medical devices by speeding up development, assessment and review.
The program applies to devices seeking premarket approval, 510(k) clearance or De Novo marketing authorization. FDA also emphasizes that Breakthrough Devices must still meet the Agency’s rigorous standards for safety and effectiveness before marketing authorization.
The program replaces the former Expedited Access Pathway and Priority Review for medical devices. Devices previously granted designation under the Expedited Access Pathway are considered part of the Breakthrough Devices Program.
Benefits for Manufacturers
The program gives manufacturers opportunities to interact with FDA experts through several program options during the premarket review phase.
According to FDA, these interactions can help manufacturers receive feedback and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submissions.
Eligibility Criteria
Devices subject to PMA, 510(k) or De Novo submissions may be eligible for Breakthrough Device designation if they meet two criteria.
First, the device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition. Second, the device must meet at least one additional criterion: it represents breakthrough technology, no approved or cleared alternatives exist, it offers significant advantages over existing alternatives, or device availability is in the best interest of patients.
How and When to Request Designation
FDA states that a Breakthrough Device designation request may be submitted at any time before the marketing submission.
Manufacturers can request designation by submitting a “Designation Request for Breakthrough Device” Q-Submission. FDA recommends that the designation request be the only request in that Q-Submission.
FDA also notes that Q-Submissions may be sent online through the CDRH Customer Collaboration Portal. In some cases, FDA may identify devices that could be good candidates for the program and recommend that sponsors consider applying.
Content of a Designation Request
FDA recommends that designation requests include:
information describing the device;
the proposed indication for use;
regulatory history;
how the device meets the statutory criteria for Breakthrough Device designation;
the type of marketing submission planned for the device.
FDA Review Timeline and Interactions
FDA intends to request any additional information needed for the designation decision within 30 days of receiving the request.
Sponsors can expect to receive FDA’s decision to grant or deny Breakthrough Device designation within 60 calendar days of FDA receiving the request.
If designation is granted, sponsors may interact with FDA through options such as sprint discussions, requests for discussion on a data development plan and requests for clinical protocol agreement. They also receive prioritized review for future submissions, including Q-Submissions, IDE applications and marketing submissions.
Public Disclosure
Before marketing authorization, FDA generally cannot publicly disclose whether a sponsor has submitted a Breakthrough Device designation request or whether the request has been granted or denied, unless the sponsor makes that information public.
FDA does maintain a list of Breakthrough Devices that have received marketing authorization, adding devices once marketing authorization has been granted.
2026 Breakthrough Device Designation Data
As of 30 June 2026, FDA’s CDRH and CBER had granted 1,320 Breakthrough Device designations, including devices originally designated under the Expedited Access Pathway.
Of these, 1,299 were granted by CDRH and 21 by CBER.
FDA also reported 210 marketing authorizations for Breakthrough Devices as of 30 June 2026, including 205 CDRH devices and five CBER devices.
The FDA page includes graphs showing designation distribution by fiscal year and by clinical panel. The clinical panel chart shows the highest number of designations in cardiovascular, neurology and orthopaedic panels.
Impact on Medical Device Manufacturers
For medical device manufacturers, the Breakthrough Devices Program can be an important regulatory pathway when developing devices intended to address serious or debilitating diseases or conditions.
Manufacturers should pay particular attention to:
whether the device meets both statutory eligibility criteria;
the intended patient population and disease or condition;
evidence supporting more effective treatment or diagnosis;
comparison with approved or cleared alternatives;
timing of the Q-Submission request;
alignment between designation request and planned marketing submission;
FDA feedback opportunities after designation;
clinical protocol and data development planning;
prioritized review expectations;
public disclosure considerations.
For manufacturers developing innovative technologies, the key message is that Breakthrough Device designation may support earlier and more structured FDA interaction, but it does not replace the need to demonstrate safety and effectiveness for marketing authorization.
