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High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory
Christopher S D Almond1, Eric A Chen, Michael R Berman
1Department of Cardiology, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts 02115, USA.
Insights
Developing pediatric mechanical circulatory support devices faces significant challenges. Early collaboration between the FDA, NHLBI, and industry is crucial for timely access to these life-saving technologies for children.
Area of Science:
- Biomedical Engineering
- Pediatric Cardiology
- Regulatory Science
Background:
- Pediatric mechanical circulatory support (MCS) remains a critical unmet need in the US.
- Development of infant- and child-sized ventricular assist devices is ongoing, supported by federal grants.
- High-risk pediatric device testing and marketing present unique epidemiologic and regulatory hurdles.
Purpose of the Study:
- To provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices.
- To review the specific challenges in developing and regulating pediatric mechanical circulatory support devices.
- To foster collaboration among stakeholders for advancing pediatric MCS.
Main Methods:
- Convened the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices in January 2006.
- Brought together leaders from the US Food and Drug Administration (FDA), National Heart, Lung, and Blood Institute (NHLBI), academia, and industry.
- Facilitated discussion on regulatory pathways and development challenges for pediatric MCS.
Main Results:
- Identified significant epidemiologic, logistic, and financial challenges for industry, regulators, and the pediatric community.
- Highlighted the need for early and continuous interaction with the FDA.
- Emphasized the importance of a shared understanding of challenges in device development.
Conclusions:
- Early engagement with the FDA and collaborative planning are essential to expedite the availability of pediatric mechanical circulatory support devices.
- Addressing the unique challenges requires a coordinated effort from all stakeholders.
- Streamlining the regulatory process can help make potentially life-saving devices accessible to children sooner.
Abstract:
Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.
