Virginia Anastassova

6 benefits of FDA Breakthrough Devices program

Breakthrough Devices programAre you developing a device that performs a more effective treatment, incorporates novel technology, or is like nothing else on the market? If the answer is “yes” then the new FDA program for breakthrough medical devices may be your best regulatory option.

The Breakthrough Devices program supersedes and combines several of the agency’s existing programs to speed access to new devices without compromising safety and effectiveness. The program covers qualifying 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE) and De Novo applications.

In an effort to implement the 21st Century Cures Act, FDA published a draft guidance in October, 2017. “Breakthrough Devices Program” will supersede “Expedited access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions” from 2015 once it is approved.

The following criteria must be met for device participation in the program:

  • Device provides more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition
  • Device represents breakthrough technologies
  • No approved or cleared alternative device is currently marketed in the US
  • Device offers significant advantages over existing approved or cleared alternatives
  • Device availability is in the best interest of patients

If your device meets the above criteria, using the breakthrough program offers several advantages to speed up market availability and patient access. Some of the perks of this new program include

  • Interactive and timely communication with FDA
  • Pre/postmarket balance of data collection
  • Efficient and flexible clinical study design
  • Review team support
  • Senior management engagement
  • Priority review

Qualifying devices will undergo priority review, moving to the front of the queue and receiving additional review resources, according to the guidance. Although the new program is designed to expedite market access, FDA notes that the review process can sometimes take longer than conventional device registration because of the novel device and technology.

Some exciting program features include “sprint” discussions with FDA on novel issues related to the device, with the goal of reaching mutual agreement with the agency within a set time period. They provide a faster mechanism for communication with FDA compared to Pre-Sub meetings, allowing device development to move forward in a timely manner. FDA says that sprint discussions should focus on a single topic and follow a defined schedule.

Data development plans (DDP) outlining data collection expectations for the entire product lifecycle should be coordinated with FDA to ensure predictable, efficient, transparent, and timely device assessment and review. The DDP may also include the balance of premarket and postmarket data collection.  FDA will consider data that may be collected postmarket rather than premarket to a level of acceptable uncertainty in the risk-benefit profile at the time of approval. This may result in less clinical data required at the time of market application with a commitment to collect more clinical data postmarket in comparison to the usual requirements. This mechanism also provides great clarity on the data required for the marketing application which helps avoid duplication of studies which saves time and resources.

The Breakthrough Devices program offers a mechanism for obtaining binding agreement in writing for clinical protocols for both FDA and the Sponsor. If changes to the agreed upon protocol are needed, they must be agreed to in writing by both FDA and the Sponsor.  Another option for protocol change is a determination from the director of the office reviewing the submission that “a substantial scientific issue essential to determining the safety or effectiveness of the device exists.”

Sponsors can agree to have regular check-ins with the agency via email, teleconference or face-to-face meetings to discuss their product’s application progress and plan for upcoming meetings.

In conclusion the Breakthrough Devices program provides several advantages for novel devices and technologies. It should be used for faster access to market.

Image: GAO. /

Virginia Anastassova, RAC, is the Regulatory Affairs Manager/ Senior QA Specialist at StarFish Medical. She brings extensive experience in quality management and regulatory affairs to our clients.


11 responses to “6 benefits of FDA Breakthrough Devices program”

  1. chethan says:

    How much is the user fees for breakthrough device programme ?

  2. Virginia Anastassova says:

    The Breakthrough program provides a pathway for expedited review. The premarketing application fees will depend on the device classification and the type of submission: 510(k), DE Novo or PMA. For example for a class III device a PMA submission is required and the PMA fees apply. If the PMA is accepted in the Breakthrough program it will be reviewed and approved faster. 2019 FDA fees for marketing application can be found here.

  3. Shari Reath says:

    Once the breakthrough designation is approved, and we have already received protocol feedback for a pivotal trial and submit a sound protocol do we still need to have several sprint discussions to have an a agreed upon clinical protocol. How many months post approval of the designation could it take to have the protocol approved?

  4. Virginia Anastassova says:

    An agreed upon clinical protocol with FDA is strongly recommended to ensure that clinical data is generated in a timely manner. An FDA approved protocol also ensures timely market approval of the breakthrough medical device which is the purpose of the Breakthrough Medical device program. The number of sprint discussions and protocol approval time will depend on the protocol complexity and FDA feedback.


  5. Dr. James Giordano says:

    Can a device that has received FDA Breakthrough status be clinically employed (ie- NOT in an FDA vetted/approved data acquisition protocol) in the assessment/diagnosis of medical patients within hospital settings in the USA and/or internationally?
    Can such services be billed (under an existing diagnostic CPT code)?

  6. Virginia Anastassova says:

    The FDA Breakthrough program provides a breakthrough designation for medical devices. It provides an opportunity for interactive and timely communications, pre/post market balance of data collection, efficient and flexible clinical study design, review team support, senior management engagement and priority review. The Breakthrough program does not exempt devices from the requirements for clinical study approval and therefore a clinical trial involving a breakthrough devices still needs to be approved by an FDA and /or an IRB depending on the risk level.

    Reimbursement for an investigational device will depend on the regulations of the country where the clinical trial is being performed.


  7. Mike says:

    In the first clause of the Breakthrough Device definition, it is listed as “products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” Is your interpretation that we may be able to address any one of those three and not all of them?
    1) More effective treatment than alternative
    2) Life-threatening disease or condition
    3) Irreversibly debilitating disease or condition

    If so, do we have any idea what the bar might be for a “more effective treatment” than an alternative?

  8. Kiefa says:

    Comapnies that are granted a Breakthrough through this program, do they stand a better change at being approved by the fda or do they product go on to get fda approval and is there a percentage rate of approvals

  9. Virginia Anastassova says:

    The Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which 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. The Breakthrough Devices Program does not offer a better chance for approval as approval is based on evidence of device safety and effectiveness and the same criteria applies as for the regular approval pathways. Approval rates for 2019 are 40% based on 5 designations and 2 approvals out of 5.


  10. Virginia Anastassova says:

    Devices subject to premarket approval applications (PMAs), premarket notification (510(k)) or requests for De Novo designation are eligible for breakthrough device designation if both of the following criteria are met:
    1. The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions
    2. The device also meets at least one of the following:
    a. Represents Breakthrough Technology
    b. Offers Significant Advantages over Existing Approved or Cleared Alternatives
    c. Device Availability is in the Best Interest of Patients
    My interpretation on the requirements for a “more effective treatment” than an alternative is that the improvement in treatment success rate should be statistically significant. This requirement can be discussed with FDA in advance via the Pre-Sub meeting mechanism to obtain feedback on the Agency’s expectations.


  11. Grace Bartoo says:

    Do you know of data on effectiveness of the program? I found this in nature – – but it doesn’t mention how many of the companies are fully marketed and if a denovo, what the average review time was.

Leave a Reply

Your email address will not be published. Required fields are marked *

Join over 6000 medical device professionals who receive our engineering, regulatory and commercialization insights and tips every month.

Website Survey

Please answer a few questions about our website.

Take Survey No Thanks