UPDATE: September 14, 2023. The FDA issued updates to the final guidance on the Breakthrough Devices Program to:
- Clarify how the Breakthrough Devices Program may apply to certain medical devices that promote health equity.
- Clarify considerations in designating devices, including eligible devices that may support innovation of new and existing technologies that address inequities.
- Clarify that the Breakthrough Devices Program may be available for certain non-addictive medical products to treat pain or addiction—consistent with the FDA’s obligations under the SUPPORT Act.
- Clarify how the FDA discloses the Breakthrough status of designated devices once they receive marketing authorization.
On Tuesday, November 14, 2023, at 1 p.m. ET, the FDA will host a webinar for the medical device industry and other interested stakeholders to discuss the updated final guidance.
On this page:
- What is the Breakthrough Devices Program?
- What are the benefits of the Breakthrough Devices Program?
- Is my device eligible?
- When do I request a Breakthrough Device designation?
- How do I request a Breakthrough Device designation?
- What do I include in a request for a Breakthrough Device designation?
- When will I find out if my device received a Breakthrough Device designation?
- What can I expect from the FDA if the Breakthrough Device designation is granted?
- Are there related programs designed to expedite the availability of certain devices that might apply to my device?
- Will the FDA announce when a device has been granted Breakthrough Device designation?
- How many devices have received Breakthrough Device designation?
- How many Breakthrough Devices have received marketing authorization?
- What guidances related to Breakthrough Devices Program are available?
- Who can I contact?
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Breakthrough Devices must meet the FDA’s rigorous standards for device safety and effectiveness in order to be authorized for marketing. The Breakthrough Devices Program reflects our commitment to device innovation and protecting the public health.
The Breakthrough Devices Program replaces the Expedited Access Pathway and Priority Review for medical devices. The FDA considers devices granted designation under the Expedited Access Pathway to be part of the Breakthrough Devices Program.
The Breakthrough Devices Program offers manufacturers an opportunity to interact with FDA experts through several different program options to efficiently address topics as they arise during the premarket review phase. This interaction can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission. Learn more about the Breakthrough Devices Program principles and features in Sections II and IV of the Breakthrough Devices Program final guidance.
Devices subject to premarket approval applications (PMAs), premarket notification [510(k)], or requests for De Novo classification request are eligible for Breakthrough Device designation if the device meets both of the following criteria:
|Criteria||Description||Refer to Guidance|
|First Criterion||The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions||Section III.B.1|
|Second Criterion||The device also meets at least one of the following:|
You can send a Breakthrough designation request for your device at any time before sending your marketing submission (for example, premarket approval [PMA], premarket notification [510(k)], or De Novo classification request).
You can request Breakthrough Device designation by submitting a "Designation Request for Breakthrough Device" Q-Submission. Your designation request should be the only request in the Q-Submission. If you are pursuing the Breakthrough Device designation while you have other requests for feedback pending, you may want to send the requests for feedback after the FDA makes a designation decision, because the designation may affect the feedback that the FDA provides on your other requests. The procedures for submitting a Q-Submission are outlined in the guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.
You may send an electronic copy (eCopy) of your Q-submission online through the CDRH Customer Collaboration Portal.
Also, the FDA may find devices that could be good candidates for the Breakthrough Devices Program and recommend that sponsors of such devices consider applying to the program.
The FDA recommends that your designation request include:
- information to describe the device,
- the proposed indication for use,
- regulatory history,
- how your device meets the statutory criteria for a Breakthrough Device, and
- what type of marketing submission you plan to submit to the FDA for your device.
Learn more about what to include in your request in Appendix 1 of the Breakthrough Devices Program final guidance.
The FDA intends to request any other information needed to inform the Breakthrough Device designation decision within 30 days of receiving your request. You can expect to receive a letter communicating the FDA's decision to grant or deny the Breakthrough Device designation request within 60 calendar days of the FDA receiving your request.
It is helpful when you are available and responsive to the FDA's requests throughout the review timeline. If the FDA does not receive the needed information to decide on a designation request promptly, it may result in denial of the Breakthrough Device designation request.
If your device is granted the Breakthrough Device designation, you can choose to interact with the FDA to obtain feedback on your device development through a variety of options including:
- sprint discussions,
- request for discussion on a data development plan, and
- request for clinical protocol agreement.
Learn more about these options in Section IV of the Breakthrough Devices Program guidance.
You will also receive prioritized review on future regulatory submissions for the device, including Q-Submissions, Investigational Device Exemption (IDE) applications, and marketing submissions.
Are there related programs designed to expedite the availability of certain devices that might apply to my device?
If your device is not eligible for a Breakthrough Device designation because it is not intended for the treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition, you may consider whether or not your device would be a candidate for the Safer Technologies Program.
Before issuing a marketing authorization, the FDA generally cannot publicly disclose whether a sponsor has submitted a Breakthrough Device designation request for a device or whether the FDA has granted or denied the request, unless the sponsor decides to make that information available to the public.
Additionally, the FDA maintains on its website a list of devices granted Breakthrough Device designation that have received marketing authorization, adding devices to the list once the device has received marketing authorization.
As of June 30, 2023, CDRH and CBER have granted 839 Breakthrough Device designations, including devices originally designated under the Expedited Access Pathway (EAP) program. Of the 839 devices granted Breakthrough Device designation, CDRH has granted 831 and CBER has granted 8.
The following graphs provide the distribution of these designations by fiscal year as well as by clinical panel.
Graph 1: Number of Granted Breakthrough Device Designations by Fiscal Year 1
*Data includes devices that were designated under the precursor Expedited Access Pathway (EAP). Since the vision and designation criteria between the precursor EAP Program and the Breakthrough Devices Program are consistent, the FDA considers devices granted designation under the EAP to be a part of the Breakthrough Devices Program.
**Indicates the 2023 data are through June 30, 2023.
Graph 2: Number of Granted Breakthrough Device Designations by Clinical Panel
CDRH and CBER Breakthrough Device Marketing Authorizations
Data as of June 30, 2023
Total of 81 Marketing Authorizations, including 77 CDRH devices and 4 CBER devices
|Manufacturer||Trade Name||Marketing Submission Number||Marketing Submission Decision Date|
|MASIMO CORPORATION||MASIMO SAFETYNET OPIOID SYSTEM||DEN200011||03/31/2023|
|BIORETEC, LTD.||REMEOS SCREW LAG SOLID||DEN220030||03/29/2023|
|REWALK ROBOTICS, LTD.||REWALK P6.0||K221696||03/02/2023|
|REFLEXION MEDICAL, INC.||REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS)||DEN220014||02/01/2023|
|PHAGENESIS LIMITED||PHAGENYX SYSTEM||DEN220025||09/16/2022|
|MAGNUS MEDICAL, INC.||MAGNUS NEUROMODULATION SYSTEM (MNS) WITH SAINT TECHNOLOGY, MODEL NUMBER 1001K||K220177||09/01/2022|
|RENOVIA, INC.||LEVA PELVIC HEALTH SYSTEM||K213913||06/30/2022|
|EARLITEC DIAGNOSTICS, INC.||EARLIPOINT SYSTEM||K213882||06/08/2022|
|SI-BONE, INC.||IFUSE BEDROCK GRANITE IMPLANT SYSTEM||K220195||05/26/2022|
|BONESUPPORT AB||CERAMENT G||DEN210044||05/17/2022|
|W. L. GORE & ASSOCIATES, INC.||GORE TAG THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE)||P210032||05/13/2022|
|FUJIREBIO DIAGNOSTICS, INC.||LUMIPULSE G ß-AMYLOID RATIO (1-42/1-40)||DEN200072||05/04/2022|
|TRANSMEDICS, INC.||ORGAN CARE SYSTEM (OCS) HEART SYSTEM||P180051/S001||04/27/2022|
|ULTRATHERA TECHNOLOGIES, INC.||GYROSTIM||K220231||04/27/2022|
|VASCUTEK, LTD.||THORAFLEX HYBRID||P210006||04/19/2022|
|INSULET CORPORATION||OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM||K203768, K203772, AND K203774*||01/27/2022|
|SPECTRANETICS, INC.||CAVACLEAR LASER SHEATH||DEN210024||12/21/2021|
|KOIOS MEDICAL, INC.||KOIOS DS||K212616||12/16/2021|
|CANARY MEDICAL, INC.||CANARY TIBIAL EXTENSION WITH CANARY HEALTH IMPLANTED REPORTING PROCESSOR (CHIRP) SYSTEM||DEN200064||08/27/2021|
|MICROTRANSPONDER, INC.||VIVISTIM PAIRED VNS SYSTEM||P210007||08/27/2021|
|SIEMENS HEALTHCARE DIAGNOSTICS, INC.||ADVIA CENTAUR ENHANCED LIVER FIBROSIS (ELF)||DEN190056||08/20/2021|
|CARLSMED, INC.||APREVO TRANSFORAMINAL IBF||K210542||06/30/2021|
|COGNOA, INC.||COGNOA ASD DIAGNOSIS AID||DEN200069||06/02/2021|
|NEUROLUTIONS, INC.||NEUROLUTIONS IPSIHAND UPPER EXTREMITY REHABILITATION SYSTEM||DEN200046||04/23/2021|
|HELIUS MEDICAL, INC.||PORTABLE NEUROMODULATION STIMULATOR (PONS)||DEN200050||03/26/2021|
|MEDTRONIC, INC.||HARMONY TPV SYSTEM||P200046||03/26/2021|
|SHOCKWAVE MEDICAL, INC.||SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER||P200039||02/12/2021|
|ABBOTT LABORATORIES||I-STAT ALINITY SYSTEM||K201778||01/08/2021|
|CARLSMED, INC.||APREVO INTERVERTEBRAL BODY FUSION DEVICE||K202034||12/03/2020|
|CERUS CORPORATION||INTERCEPT BLOOD SYSTEM FOR PLASMA||BP130076/S034||11/24/2020|
|NIGHTWARE, INC.||NIGHTWARE KIT||DEN200033||11/06/2020|
|FOUNDATION MEDICINE, INC.||FOUNDATIONONE LIQUID CDX||P200006||10/26/2020|
|ROCHE MOLECULAR SYSTEMS, INC.||COBAS BKV||K202215||09/02/2020|
|MEDTRONIC MINIMED, INC.||MINIMED 770G SYSTEM||P160017/S076||08/31/2020|
|FOUNDATION MEDICINE, INC.||FOUNDATIONONE LIQUID CDX||P190032||08/26/2020|
|GUARDANT HEALTH, INC.||GUARDANT360 CDx||P200010||08/07/2020|
|ROCHE MOLECULAR SYSTEMS, INC.||COBAS EBV||DEN200015||07/30/2020|
|AMBU INNOVATION GMBH||AMBU DUODENO SYSTEM||K201098||07/17/2020|
|BAY LABS, INC.||CAPTION GUIDANCE||DEN190040||02/07/2020|
|BOSTON SCIENTIFIC||EXALT MODEL D, SINGLE-USE DUODENOSCOPE, EXALT CONTROLLER||K193202||12/13/2019|
|TUSKER MEDICAL||TULA SYSTEM||P190016||11/25/2019|
|ORASURE TECHNOLOGIES||ORAQUICK EBOLA RAPID ANTIGEN TEST||DEN190025||10/10/2019|
|CVRX, INC.||BAROSTIM NEO SYSTEM||P180050||08/16/2019|
|IMPULSE DYNAMICS, INC.||OPTIMIZER SMART SYSTEM||P180036||03/21/2019|
|SPIRATION, INC.||SPIRATION VALVE SYSTEM||P180007||12/03/2018|
|AVITA MEDICAL, LLC.||RECELL AUTOLOGOUS CELL HARVESTING DEVICE||BP170122||09/20/2018|
|PULMONX CORPORATION||ZEPHYR ENDOBRONCHIAL VALVE SYSTEM||P180002||06/29/2018|
|MEDTRONIC MINIMED, INC.||MINIMED 670G SYSTEM||P160017/S031||06/21/2018|
|CLINICAL RESEARCH CONSULTANTS, INC.||CUSTOMFLEX ARTIFICIAL IRIS||P170039||05/30/2018|
|CONCENTRIC MEDICAL, INC.||TREVO PRO VUE RETRIEVER AND TREVO XP PRO VUE RETRIEVER (TREVO RETRIEVER)||K173352||02/15/2018|
|BANYAN BIOMARKERS, INC.||BANYAN BTI||DEN170045||02/14/2018|
|FOUNDATION MEDICINE, INC.||FOUNDATIONONE CDX||P170019||11/30/2017|
|SI-BONE, INC||IFUSE BEDROCK GRANITE IMPLANT SYSTEM||K222774||12/22/2022|
|ROCHE DIAGONOSTICS||ELECSYS B-AMYLOID (1-42) CSF II,
ELECSYS PHOSPHO-TAU (181P) CSF
|ULTROMICS LIMITED||ECHOGO HEART FAILURE||K222463||11/23/2022|
|CALA HEALTH, INC.||CALA KIQ||K222237||11/22/2022|
|CARLSMED, INC.||APREVO ANTERIOR LUMBAR INTERBODY FUSION DEVICE WITH INTERFIXATION||K222009||11/22/2022|
|ARGENTUM MEDICAL, INC.||SILVERLON WOUND CONTACT, BURN CONTACT DRESSINGS||K221218||10/26/2022|
|RENALYTIX AI, INC.||KIDNEYINTELX.DKD||DEN200052||06/29/2023|
|ABBOTT MEDICAL||AVEIR DR LEADLESS SYSTEM||P150035/S003||06/29/2023|
|AVITA MEDICAL AMERICAS, LLC.||RECELL AUTOLOGOUS CELL HARVESTING DEVICE||BP220799||06/16/2023|
|PREMIA SPINE, LTD.||TOPS SYSTEM||P220002||06/15/2023|
|AVITA MEDICAL AMERICAS, LLC||RECELL AUTOLOGOUS CELL HARVESTING DEVICE||BP170122/S502||06/07/2023|
|ENDOLOGIX, LLC.||DETOUR SYSTEM||P220021||06/07/2023|
|CERIBELL, INC.||CERIBELL STATUS EPILEPTICUS MONITOR||K223504||05/23/2023|
|BRAHMS GMBH, PART OF THERMO FISHER SCIENTIFIC||B·R·A·H·M·S SFLT-1/ PLGF KRYPTOR TEST SYSTEM||DEN220027||05/18/2023|
|SWING THERAPEUTICS, INC.||STANZA||DEN220083||05/09/2023|
|W. L. GORE & ASSOCIATES, INC.||GORE TAG THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE)||P210032/S007||05/02/2023|
|NOCTRIX HEALTH, INC.||NTX100 TONIC MOTOR ACTIVATION (NTX100 TOMAC) SYSTEM||DEN220059||04/17/2023|
|MOXIMED, INC.||MISHA KNEE SYSTEM||DEN220033||04/10/2023|
|BRAINCOOL AB||THE COORAL SYSTEM||DEN210027||10/14/2022|
* This Breakthrough designation was granted for a single system, which is now comprised of multiple component devices authorized via multiple marketing submissions, as listed in the table.
- Final Guidance: Breakthrough Devices Program
- Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (Benefit Risk Final Guidance)
- Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics - Guidance for Industry and Food and Drug Administration Staff
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
For any questions about the Breakthrough Devices program, please contact BreakthroughDevicesProgram@fda.hhs.gov.
- 1As of July 12 2023, the number of Breakthrough Device designations granted in FY2022 has been updated to include two additional designations inadvertently omitted due to an administrative error.