Home 5 Clinical Diagnostics Insider 5 Want Breakthrough Device Designation? You’ll Need to Consider Health Equity

Want Breakthrough Device Designation? You’ll Need to Consider Health Equity

by | Nov 21, 2022 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

In draft guidance, the FDA is proposing that medical device makers will need to consider how accessible their products are to underserved populations.

While recognition of the current socioeconomic and racial disparities in health care is nothing new, the COVID-19 public health emergency (PHE) and change in presidential regime have clearly accelerated the efforts to address them. A recent example, proposed in draft guidance, is the FDA’s drive to factor a new medical device’s health benefits to disadvantaged populations into the determination of whether to grant it breakthrough device approval.

The Current FDA Breakthrough Device Program

In December 2016, the US adopted a sweeping law called the 21st Century Cures Act (Cures Act) to accelerate “discovery, development and delivery” of new medical treatments and technologies. Among other things, the Cures Act established an FDA priority review program for “breakthrough” devices patterned on the agency’s breakthrough pathway for new drugs.1 To qualify for breakthrough device designation, the device maker/applicant must show that the device provides for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition, and meets one of the following criteria:

    • It represents a breakthrough technology;

    • It has no approved or cleared alternative;

    • It provides significant advantages over currently approved or cleared alternatives in reducing the need for hospitalization, improving patient quality of life, facilitating patient ability to manage their own care; or

    • Its availability is in the best interest of patients.

However, under current guidelines, access to the device is not something the FDA considers when deciding whether it would be “more effective” than existing options and alternatives. As a result, the breakthrough device designation process may perpetuate existing health disparities, e.g., by clearance of devices that may be clinically more effective than current technologies, but cannot be easily accessed because they are far too expensive for most individuals to afford.

The New FDA Guidance

On Oct. 21, the FDA proposed new guidance to rectify these problems.2 Entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care,” the new draft guidance is technically a revision of breakthrough designation program guidance that the agency issued in 2018.3 Its purpose is “to clarify how the program may be applicable to certain devices that benefit populations impacted by health and/or health care disparities.”

First, the guidance stresses that the agency has and will continue to consider “the totality of the information” about the proposed device in determining whether it is likely to “provide for more effective treatment or diagnosis.”

To make good on that commitment, the FDA is proposing to add a new section called “Reducing Disparities in Health and Health Care” to the guidance provisions explaining the breakthrough device designation. Such disparities exist “across many dimensions,” the guidance explains, “including race, ethnicity, socioeconomic status, age, sex, disability status, sexual orientation, gender identity, language, and location.” Accordingly, the agency says that it will now consider “technologies and device features” that reduce health and/or healthcare disparities and promote health equity when assessing whether clearing a proposed device would provide for more effective treatment or diagnosis.

JAMA Study Documents COVID-19 Testing Disparities

Much of the renewed impetus to promote equity and accessibility in health care has come from studies documenting the significant disparities in COVID-19 testing and treatment. One example is a new study published in JAMA Network Open on Nov. 9, evaluating the effectiveness of the Test to Treat program created by the Biden administration to provide accessible, one-stop locations where people across the country can easily access free COVID-19 tests, antiviral treatments, and clinical advice.4 While designed to break down geographic disparities, the study concludes that Test to Treat has perpetuated them, particularly for people living in rural areas and other historically underserved populations. Key findings:

·       15 percent of the total US population lives more than 60 miles away from a Test to Treat site, including 17 percent of those ages 65 and older;
·       59 percent of individuals in rural areas live more than 60 miles from a site;
·       30 percent of American Indian or Alaskan Native peoples have long drives to sites, the highest of any demographic group.

Takeaway: Impact on Device Makers Seeking Breakthrough Device Designation

If and when the new guidance is finalized (comments on the draft guidance are due by Dec. 20), laboratories and device makers seeking breakthrough device designation will have to be sensitive to and capable of navigating the new FDA health disparity regime. The first step will be to understand what the agency will be looking for in applying the criteria. The guidance outlines three things the agency will be looking for in determining whether a new device would reasonably be expected to provide for more effective diagnosis and treatment.

Tailoring Devices to Social Characteristics: According to the guidance, the agency will favor technologies and device features “tailored to address characteristic differences…arising from social factors, phenotypic variations, pathophysiology, and/or response to treatment.” For example, a device would likely be considered as leading to more effective treatment or diagnosis “if it is designed to address a pathophysiological or clinical characteristic associated with certain populations that could have a clinically meaningful impact for the treatment or diagnosis of the condition in those populations.”

Targeting Diseases Affecting Underserved Populations: As another aspect of this new approach, the FDA says it will look favorably upon devices for treating or diagnosing rare life threatening or irreversibly debilitating conditions affecting populations with unmet needs that have limited diagnostic and treatment options.

Devices that Are Widely Accessible: “Another major dimension of health and health care disparities is accessibility to quality health care,” the guidance explains, defining accessibility as the capacity of an individual or group to benefit from the advantages that the device offers. Accessibility is necessary for new devices to make a “clinically meaningful impact.” Examples include “user features that are adaptable or more easily used by diverse populations or allow for use in more diverse settings,” particularly among patient populations with limited or no alternative options.


    1. https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf

    1. https://www.fda.gov/media/162413/download

    1. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program

    1. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2798225

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