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  1. How to Study and Market Your Device

Breakthrough Devices Program

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?

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.

What are the benefits 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.

Is my device eligible?

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:  
  1. Represents Breakthrough Technology
Section III.B.2.a
  1. No Approved or Cleared Alternatives Exist
Section III.B.2.b
  1. Offers Significant Advantages over Existing Approved or Cleared Alternatives
Section III.B.2.c
  1. Device Availability is in the Best Interest of Patients
Section III.B.2.d

When do I request a Breakthrough Device designation?

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).

How do I request a Breakthrough Device designation?

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.

What do I include in a request for a Breakthrough Device designation?

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.

When will I find out if my device received Breakthrough Device designation?

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.

What can I expect from the FDA if Breakthrough Device designation is granted?

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.

Will the FDA announce when a device has been granted Breakthrough Device designation?

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.

How many devices have received Breakthrough Device designation?

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

Bar graph showing the number of Breakthrough Device designations granted by fiscal year.  11 in 2015, 12  in 2016, 19  in 2017, 55 in 2018, 110 in 2019, 151 in 2020, 206 in 2021, 166 in 2022, 109 in 2023 through June 30, 2023

*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

Bar graph showing the number of Breakthrough Device designations granted by clinical panel through June 30, 2023. 179 Cardiovascular,  154 Neurology,  101 Orthopedic,  68 Gastroenterology & Urology,  56 General & Plastic Surgery,  36 Anesthesiology,  33 Immunology,  33 Molecular Genetics,  31 Clinical Chemistry,  30 Pathology,  28 Microbiology,  26 Radiology,  18 Ophthalmic,  11 Hematology , 9 General Hospital,  8 Physical Medicine,  7 Ear, Nose, Throat,  4 Dental,  4 Obstetrics,  3 Clinical Toxicology.

How many Breakthrough Devices have received marketing authorization?

Below is a list of CDRH and CBER Breakthrough Devices that have obtained marketing authorization.

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
ABBOTT LABORATORIES TBI K223602 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
NEUROMETRIX, INC. QUELL-FM DEN210046 05/18/2022
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
CARTIHEAL, LTD. AGILI-C P210034 03/29/2022
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
APPLIEDVR, INC. EASEVRX DEN210014 11/16/2021
SYNCTHINK, INC. EYE-SYNC K202927 10/02/2021
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
PAIGE.AI PAIGE PROSTATE DEN200080 09/21/2021
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
PEAR THERAPEUTICS RESET-O K173681 12/10/2018
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
IDX, LLC IDX-DR DEN180001 04/11/2018
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
EMPATICA SRL EMBRACE K172935 01/26/2018
FOUNDATION MEDICINE, INC. FOUNDATIONONE CDX P170019 11/30/2017
INSIGHTEC EXABLATE P150038 07/11/2016
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
K221842 12/07/2022
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.

What guidances related to the Breakthrough Devices Program are available?

Who can I contact?

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.
 
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