FDA Breakthrough Device Program - Requirements and Main Features 

The aim of the FDA Breakthrough Devices Program is to ensure timely market access for devices that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. In this context, whether a disease or condition is considered "irreversibly debilitating" is contingent upon its effect on factors such as survival rates, daily functionality, and the probability that, if not treated, it will advance to a more severe state.


Manufacturers of medical devices or device-led combination products can enter the program on a voluntary basis. The primary goal of the program is to foster innovation and provide timely access to these devices for patients and healthcare providers, expediting their development, assessment, and approval processes, while upholding the FDA’s rigorous safety and efficacy standards.


The newest version of the FDA Guidance "Breakthrough Device Program" additionally emphasized health equity by addressing disparities in health and healthcare, including factors like age and disability, and highlighting accessibility as an assessment criterion for device effectiveness. Therefore, the FDA plans to take into account devices that would enable more effective treatment or diagnosis, particularly in populations that experience disparities in health and healthcare access, such as those containing features that are adaptable or more easily used by diverse populations or that are suitable for use in more diverse settings.


The aim of this blog post is to provide an overview of the requirements and principles of the FDA Breakthrough Device Program as outlined in the guidance mentioned above.



The Breakthrough Device designation request is the process through which sponsors seek inclusion in the Breakthrough Devices Program and the FDA evaluates and conveys its decision regarding this request.


At this stage, it is essential for sponsors to clearly specify the indications for use for which they are seeking this designation since these indications might be directed at a specific subgroup within a larger population affected by the disease.


Importantly, the FDA requires sponsors to submit a request for Breakthrough Device designation before they submit the marketing application. Requests for designation that are included in a marketing submission or those submitted after a marketing submission has already been received will not be considered.


The designation criteria for the program are defined in section 515B(b) of the FD&C Act (21 U.S.C. 360e-3(b)). Eligible devices must meet the first criterion and at least one of the sub-paragraphs listed for the second criterion in order to be granted Breakthrough Device designation.


The first criterion requires devices to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.

To assess the potential of the device to offer improved treatment or diagnosis compared to the current standard of care (SOC) in the United States for the population specified in the indications for use, sponsors should present evidence of a reasonable expectation that this is the case. This demonstration shall be based on the device's ability to operate as intended (technical success) and evidence that a functioning device could offer more effective treatment or diagnosis for the identified disease or condition (clinical success). Literature searches as well as bench, animal, or clinical studies can be used to this end, but a complete set of clinical data is not required for designation.


The second criterion additionally requires devices to either:

-       represent breakthrough technologies (e.g. a novel technology or a novel application of an existing technology);

-      have no approved or cleared alternatives (with regard to the current standard of care for the specific indication (including the disease stage) for which the product is being developed);

-      offer significant advantages over existing approved or cleared alternatives, including the potential, compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies;

-       have the availability that is in the best interest of patients.



The Breakthrough Devices Program consists of two phases:


-       In the Designation Request phase, a sponsor requests that FDA grants device Breakthrough Device designation (see above).

-      Once the device has received Breakthrough Device designation, the second phase consists of a series of actions to expedite the development and to prioritize the review of subsequent regulatory submissions for the device.


During this process, the FDA requires interactive and timely communication with the sponsor through sprint discussions on a specific topic, a defined interactions schedule, and clear documentation of interactions and conclusions.


To profit the most from the priority review status within the Breakthrough Devices Program, it is essential that the sponsor's dedication to addressing scientific and regulatory matters aligns with that of the FDA. Achieving expedited review can only be accomplished through a mutual commitment to fulfilling all regulatory and scientific requirements.



The FDA’s approach to development and market authorization for Breakthrough Devices aims to strike a balance between expediting the approval process and ensuring the safety and effectiveness of the devices. To this end, the following aspects are taken into consideration.


3.1 Pre-/Postmarket Balance for Data Collection


In the case of PMAs (Pre-Market Approval applications) designated as Breakthrough Devices, the FDA aims to employ timely postmarket data collection, as long as it is scientifically suitable and does not negatively impact the safety and effectiveness of the device. The amount and nature of data that may be collected in the postmarket, rather than premarket, phase will be determined in conjecture with the benefit-risk profile of the device at the time of approval and the extent of uncertainty that may be acceptable at that time point.


3.2 Efficient and Flexible Clinical Study Design


The FDA aims to implement measures that ensure that the design of clinical trials is as efficient and adaptable as feasible, given scientific appropriateness. This may encompass considerations such as establishing predefined endpoints related to the smallest clinically significant effect, utilizing intermediate and surrogate endpoints (provided there is evidence demonstrating their ability to reasonably predict the clinical advantages of a device), employing composite endpoints (along with a clear rationale for the significant effect size), and exploring adaptive study designs.


3.3 Expedited Review of QMS Compliance


In light of the Breakthrough Device Program, the FDA might require less quality system and manufacturing information in a PMA (Pre-Market Approval) if the sponsor meets the statutory and regulatory prerequisites through an alternative method, such as when the sponsor has a strong history of compliance with quality systems and when there are no new manufacturing concerns that could negatively affect the quality or performance of the product. In specific instances, the FDA may choose to conduct an inspection of particular manufacturing sites only after granting approval for a Breakthrough Device.


If you need help with your application for Breakthrough Device Designation and communication with the FDA, please contact us at: info@quaregia.com. We have 65+ years of experience with medical devices in all their facets.

Last updated 2023-10-09