The Scarcity of Approved Pediatric High-Risk Medical Devices | Medical Devices and Equipment | JAMA Network Open | JAMA Network
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Invited Commentary
June 22, 2021

The Scarcity of Approved Pediatric High-Risk Medical Devices

Author Affiliations
  • 1Department of Pediatrics, Children’s Hospital Los Angeles, Los Angeles, California
JAMA Netw Open. 2021;4(6):e2112760. doi:10.1001/jamanetworkopen.2021.12760

“Children are not little adults” is a common refrain in pediatrics, intended to stress the differences in physiology, neurodevelopment, disease presentation, diagnosis, and treatment. Unfortunately, these differences between children and adults also extend to how we fund our systems of care and innovation. Although individuals younger than 18 years represent nearly one-quarter of the US population, less than 12% of the National Institutes of Health budget funds pediatric research, and less than 10% of all health care spending is for pediatrics.1,2 Pediatric medical devices, which are critical tools for the diagnosis and treatment of disease in children, also are affected by this disparity and have long lagged behind their adult counterparts in terms of availability, options, and innovation.3 The result of this has been that for certain diseases, children have either no device options, inadequate options, or adult devices that are modified and used off-label with little or no safety or efficacy data for their use in pediatrics.

The study by Lee et al4 provides us with an interesting opportunity to quantify this gap among the highest risk medical devices: class III devices requiring a premarket approval (PMA). The US Food and Drug Administration (FDA) defines these high-risk devices as those that “support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury,”5 and include such products as pacemakers, defibrillators, implanted prosthetics, and high-frequency ventilators.4 To better understand which currently approved devices include a pediatric indication, Lee et al4 leveraged the OpenFDA application programming interface to access all publicly available PMA documents and then used natural language processing to abstract data from thousands of documents. They identified 102 unique devices with an explicit pediatric indication, with most of these indicated in older children and adolescents. (For a sense of scale, the OpenFDA database contains thousands of PMA documents dating back to 1976.) Only 42 devices were indicated for infants and neonates. Cardiology, ophthalmology, and clinical chemistry were the clinical specialties most commonly associated with devices.

These results do not imply that there are only 102 pediatric devices approved by the FDA. As Lee et al4 point out in their discussion of limitations, there are several factors that potentially contribute to missed devices. Some devices designed specifically for pediatrics do not actually mention a pediatric patient population, even though the device treats a pediatric-specific condition (see the authors’ discussion of the Amplatzer Piccolo Occluder). They also did not include devices approved through the Humanitarian Device Exemption (HDE) pathway, which accounts for a substantial number of high-risk pediatric devices. Finally, their search and identification strategy requires the presence of certain key words in the PMA document, so devices intended for pediatrics that did not use those key search terms would not have been included in the study. Despite these limitations, the overall results are consistent with other reports on the lack of high-risk devices with pediatric indications. Hwang at al3 were only able to identify 22 devices with pediatric indications among all approved PMAs and HDEs from 2008 to 2011, and only 1 of those had been studied in children younger than 18 years. An internal analysis done by the FDA in 2018 found that only 18 of 66 devices that received a PMA or HDE approval in 2017 had a pediatric indication in their labeling.6 Interestingly, an internal panel of pediatric experts reviewed those same PMAs and found that 42 of the remaining 48 devices with an adult-only indication had the potential to be used in pediatrics.6 Taken together, it would be reasonable to conclude that the innovative methods of Lee et al4 produced results that are indeed representative of the current landscape of pediatric medical devices.

The study by Lee et al4 highlights 4 key takeaways that should inform the efforts of future researchers, regulators, and legislators. First, clear guidance on pediatric labeling for medical devices is needed. The FDA has already produced labeling guidance for drugs and biologics, but no such guidance exists for devices.7 When developed, the labeling information should be collected in a structured and standardized way. If the goal is to produce more and better devices indicated for children, then we can only assess our success or failure if the information is measurable.

Second, the definitions of pediatric and pediatric subgroup age ranges may need revisiting. Currently, the FDA segments pediatrics into neonates (birth through the first 28 days of life), infants (aged 29 days to <2 years), children (aged 2 to <12 years), and adolescents (aged 12-21 years) for medical devices. These ranges, particularly those for children and adolescents, do not map to more commonly used developmental or physiological categories in clinical practice. For example, if a device requires some amount of cooperation from the patient, then a more meaningful group might be starting somewhere between ages 4 and 7 years (ie, when use of the device is developmentally appropriate). To further confuse the issue, on the drug and biologic side, the FDA defines pediatrics as being from 0 to 16 years of age.7

Third, additional efforts are required to modernize the FDA’s data infrastructure. The agency has made substantial progress over the past decade in terms of transparency and access by creating the OpenFDA application programming interface (which was used by Lee et al4), the FDA Data Dashboard, and the Medical Device Databases. However, these databases mostly contain text documents and PDFs, with very little structured data that can be leveraged for large-scale analysis. The use of natural language processing by Lee et al4 is an exciting new approach to dive deep into 40 years’ worth of FDA data and documents, but unlocking that data into more accessible formats will be critical to enable better research, reporting, and data-informed decision-making.

Fourth, more needs to be done to accelerate pediatric medical device innovation. The FDA has introduced a number of exciting regulatory and programmatic initiatives over the past 2 decades, including expansion of the HDE program, launching the Pediatric Device Consortia Program, collaborating with the National Evaluation System for Health Technology to create pediatric Real World Evidence demonstration projects, and its newest initiative, The System of Hospitals for Innovation Pediatrics—Medical Devices. The substantial financial and market barriers faced by pediatric medical device innovators need to be addressed by a broad coalition of stakeholders, not just the FDA.8

Lee et al4 have given us a fresh perspective on the scale of the problem in pediatric high-risk medical devices. Natural language processing and other advanced analytics and informatics techniques may very well be the future of analyzing this and other regulatory challenges. Another common refrain in the health care innovation world is, “Healthcare is hard; medical devices are harder; pediatric medical devices are the hardest.” By better understanding and quantifying the problems we face, we may be better positioned to solve them.

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Article Information

Published: June 22, 2021. doi:10.1001/jamanetworkopen.2021.12760

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Espinoza JC. JAMA Network Open.

Corresponding Author: Juan C. Espinoza, MD, Department of Pediatrics, Children’s Hospital Los Angeles, 4650 Sunset Blvd, Mailstop 76, Los Angeles, CA 90027 (

Conflict of Interest Disclosures: Dr Espinoza reported receiving grants from the US Food and Drug Administration (FDA) (grant number P50FD006425).

Disclaimer: The contents are those of the author and do not necessarily represent the official views of, nor an endorsement, by the FDA, US Department of Health and Human Services, or the US government. For more information, please visit

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