Home 5 Clinical Diagnostics Insider 5 FDA’s Breakthrough Designation Now Includes Health Equity Provision

FDA’s Breakthrough Designation Now Includes Health Equity Provision

by | Apr 26, 2024 | Clinical Diagnostics Insider, FDA-dtet

Though not expected to drastically change the program, new component gives device makers another way to strengthen their submissions

The U.S. Food and Drug Administration (FDA) has introduced a facet into its Breakthrough Devices program that laboratories and companies that develop new tests should take heed of: A new component that takes health equity into consideration as part of the review process.

The FDA introduced final guidance last September on the revamped Breakthrough Devices Program, as mandated by the 21st Century Cures Act (Cures Act), a 2016 federal law intended to streamline the development of new medical devices, including laboratory tests.1 According to the FDA’s guidance, the agency “recognizes the urgent public health need for innovative technologies that help to reduce barriers to achieving health equity and help to improve health outcomes across diverse populations.”2

Considering this need, the FDA adds that, as part of the review process for Breakthrough Device Designation it will take into account “technologies and device features” that may help address gaps in healthcare “and promote health equity by providing for more effective treatment or diagnosis in populations that exhibit health and healthcare disparities.”2

To that end, the FDA noted that the Breakthrough program can help provide such populations faster access to medical devices that may address disparities. The agency adds that it “considers technologies and device features tailored to address characteristic differences, such as those arising from social factors, phenotypic variations, pathophysiology, and/or response to treatment, when evaluating if there is a reasonable expectation that the device may provide for more effective treatment or diagnosis as compared to the current standard of care.”2

How that will impact laboratory tests that are submitted for Breakthrough Device Designation remains to be seen.

“The guidance revisions are fairly recent and so there has not yet been enough time for a device that has been granted breakthrough based on this new policy to have also gone through FDA clearance or approval,” said James Mullally, vice president of in vitro diagnostic regulatory affairs for MCRA, a Washington, DC-based consulting firm that focuses on lab tests and medical devices.

However, Mullally observed that the guidelines have received a positive response from MCRA clients who develop in vitro lab tests. “The guidance revision provides another avenue in which to bolster the strength of a submission and potentially push it across the finish line. So, the reaction from test developers has been very favorable,” he said, adding that he expects the new guidelines will eventually move the needle on health equity.

A new focus on social determinants of health

Although the Cures Act was enacted nearly a decade ago, healthcare disparities have received significant focus by policymakers in recent years, spurred on by the COVID-19 pandemic that began in the US in March 2020. Many providers and even health plans have been channeling resources into non-clinical equity issues such as housing.3

The laboratory community has also focused on healthcare disparities. For example, the Clinical Laboratory Improvement Advisory Committee (CLIAC) extensively discussed health equity at its October 2020 meeting, with attendees offering several solutions to help achieve it.4

Marissa White, MD, a pathologist at Johns Hopkins University School of Medicine discussed how laboratories could address disparities by “offering flexible testing site hours and ensuring that laboratory information is equitable and mindful of cultural and linguistic competencies.”4 Nicole Lurie, MD of the Harvard Medical School and the George Washington University School of Medicine added that lack of internet access can prevent populations from accessing lab test results and telemedicine services. Lurie also noted “the need for checklists and other tools to identify patient resources needed to manage their care or their social situation; and the need for healthcare workers to serve as ambassadors or educators in their community for advocacy of testing and vaccinations.”4

She provided the following areas (six “As”) the laboratory community can target to address disparities:

  • Access;
    • algorithms and reference ranges,

  • awareness,

  • action,

  • adult education, and

  • advocacy.

Following the discussion, CLIAC voted to recommend that the Centers for Disease Control and Prevention develop guidelines for US labs to help address health disparities, “resulting in a national plan to champion laboratory engagement in closing gaps in care that broadly address social determinants of health.”4

A presentation at the spring 2023 CLIAC meeting offered an update on the health equity activities of the CDC’s Division of Laboratory Systems. These activities include:5

    • Improving access to electronic test orders and results for underserved communities

    • Supporting increased diversity and training of public health workers

    • Improving communication of test results to non-English speaking populations

  • Increasing access to point-of-care testing during public health emergencies

Where inequities exist in lab testing

Research on equity issues in the laboratory sector remains relatively scarce, but it exists. A May 2023 study published in The Journal of Applied Laboratory Medicine concluded that patients whose first language is other than English or were in a low-income demographic “were significantly less likely to be offered access to patient portals and to review laboratory test results.” Such reviews can lead to identifying medical errors and improving medication adherence, the study noted.6

Mullally adds that testing inequities also likely exist “where a particular disadvantaged demographic group has a significantly higher incidence rate of a given condition.” He says that “a lack in availability of testing for this condition could lead to healthcare disparities in this population, and thus a new test that is submitted for Breakthrough Designation might be able to leverage this potential disparity in their Breakthrough submission.”

Mullally said such an example would be testing for sickle cell disease, which impacts Black people at a far higher rate than any other portion of the US population. Another is kidney failure, which though an issue in other demographics, also impacts Black people at a high rate.

The health equity facet of a laboratory test or medical device will not make or break its receiving a Breakthrough Designation. The primary criterion will continue to be whether the submission “provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.”7

It’s also important to note that such FDA guidances are not requirements companies must follow. As the FDA notes, “unless specific regulatory or statutory requirements are cited” such documents provide the agency’s “current thinking on a topic” and offer recommendations only.2


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

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

    1. https://www.cvshealth.com/news/community/cvs-health-invested-185-million-in-affordable-housing-in-2021-to.html

    1. https://www.cdc.gov/cliac/docs/summary/cliac_summary_oct2020.pdf

    1. https://www.cdc.gov/cliac/docs/april-2023/9_DLS_Health_Equity_Activities.pdf

    1. https://academic.oup.com/jalm/article-pdf/8/3/635/50194438/jfac128.pdf

  1. https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program#s1


Key recent FDA approvals of laboratory-related platforms, IVD devices, and over-the-counter tests and products include:

Company Name Approval Date What Was Approved Complexity
Roche Molecular Systems April 12, 2024 Cobas 6800 and 8800 malaria nucleic acid tests Moderate
Aceso Laboratories April 12, 2024 ACESO Early Pregnancy Test Waived
Siemens Healthcare Diagnostics Inc. April 12, 2024 ADVIA Centaur® XP Immunoassay System Moderate
Aceso Laboratories April 5, 2024 14 approvals for the Atida Single Drug Drug of Abuse Strip Test Moderate
Siemens Healthcare Diagnostics Inc. April 2, 2024 Atellica CH Analyzer Moderate
Aceso Laboratories April 2, 2024 Four approvals for the Atida hCG Pregnancy Rapid Combo Test Moderate
Instrumentation Laboratory April 2, 2024 18 approvals for its ACL Elite platform for HemosIL testing High and Moderate
Roche Diagnostics March 29, 2024 Six approvals for a fecal sample matrix test High
Siemens Healthineers March 29 and 28, 2024 24 approvals for an automated blood coagulation analyzer High and Moderate
Sysmex March 29, 2024 10 approvals for an automated blood coagulation analyzer High and Moderate
Beckman Coulter March 29, 2024 Four approvals for a fecal sample matrix test High
Acro Biotech March 28, 2024 Two approvals for a pregnancy combination test Moderate and Waived
Germaine Laboratories March 28, 2024 An approval for the AimScreen fentanyl test Waived
TransMed Company March 28, 2024 14 approvals for an in vitro urine test cup Waived
AZOVA, Inc. March 28, 2024 An approval for a fecal immunochemical test for checking colon health Waived
Becton Dickinson & Co. March 28, 2024 An approval for the BD Phoenix automated microbiology system High
Quidel Corporation March 28, 2024 An approval for a COVID-19 test Waived
Roche Diagnostics March 27, 2024 Two approvals for core antibody tests for hepatitis B and hepatitis C Moderate
Source: FDA CLIA database.

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