The U.S. Food and Drug Administration (FDA) has developed a new draft guidance that updates the agency’s Breakthrough Devices Program and provides clarifications that address health and healthcare disparities in the nation. The eight-page draft, released Oct. 21, outlines ways that the Breakthrough Devices Program evaluates medical devices to help address issues of recognition and accessibility. 

The subsection of the draft, “Reducing Disparities in Health and Health Care,” was updated to include health disparities and inequalities due to:

  • Age
  • Disability
  • Ethnicity
  • Gender identity
  • Language
  • Location
  • Race
  • Sex
  • Sexual orientation
  • Socioeconomic status

The agency noted that when these disparities are addressed, the health equity, quality of life, and health outcomes of all patients are improved. In order to address these disparities, the FDA is considering issuing clarifications to the Breakthrough Devices Program. 

The agency will give particular consideration to “technologies and device features that may help to address health and/or health care disparities and promote health equity by providing for more effective treatment or diagnosis in populations that exhibit health and health care disparities.”

One of the ways that the FDA notes that disparities manifest is in an inability to recognize and address the different ways that diseases and health conditions manifest based on race, ethnicity, sex or other categories. For example, one common disparity between biological sexes is how they experience heart attacks. According to the American Heart Association, while male and female patients may experience chest pain, female patients suffering a heart attack may also have jaw or back pain in addition to nausea or shortness of breath.

The FDA states that whether due to implicit bias, lack of knowledge or technology, these alternate presentations can delay or impair diagnosis and treatment. This lack of recognition is demonstrated in the deficiency of devices with diagnostic and treatment capabilities to treat the alternate manifestations of health complications.

With the Breakthrough Device Program, the FDA can provide quicker access to devices that address these unmet needs in populations experiencing disparities. The agency’s draft guidance suggests giving technologies and devices that address disparities in recognition and care increased consideration in the program. Usually, to qualify as a breakthrough device, the machinery would need to prove it was superior to the current standard of care.

The FDA also noted that there are disparities in care for patients with rare, life-threatening, or debilitating diseases. The most common disparity is a lack of access to diagnostic or treatment options. In an effort to address this disparity, the FDA draft guidance includes consideration for devices with a “reasonable expectation” of being more effective in treating or diagnosing these rare conditions for these groups.

The final major cause of health disparities, according to the FDA, is accessibility. The agency states that barriers such as inequities of care may prevent underserved populations from obtaining access to medical treatment or diagnosis due to a lack of quality medical care. Even if there is a device that could treat patients, a lack of accessibility to that device can keep patients from receiving care. To address this disparity, new devices that may enable increased accessibility through versatility or ease of use may be considered in addition to clinically meaningful impact, risks and benefits.