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Postmarketing trials and pediatric device approvals
Thomas J Hwang1, Aaron S Kesselheim2, Florence T Bourgeois3
1Faculty of Arts and Sciences, Harvard University, Cambridge, Massachusetts; Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts;
Insights
Most high-risk pediatric devices are approved using data from adults, not children. Few post-market studies require additional pediatric patient testing before these medical devices are available.
Area of Science:
- Pediatric medical device research
- Regulatory science
- Clinical trial design
Background:
- Few medical devices are specifically approved for pediatric use.
- The 2007 Pediatric Medical Device Safety and Improvement Act aimed to boost pediatric device development.
- Evidence supporting pediatric device approval is not well-documented.
Purpose of the Study:
- To describe the trial evidence used for high-risk pediatric device approvals.
- To analyze the characteristics of clinical trials for pediatric devices.
- To examine postmarketing study requirements for pediatric devices.
Main Methods:
- Identified high-risk (class III) therapeutic devices approved for children (2008-2011).
- Collected data on trial design (randomization, blinding, controls, endpoints) and participant age.
- Reviewed US Food and Drug Administration (FDA)-mandated postmarketing trials.
Main Results:
- 25 devices approved via premarket approval or humanitarian device exemption.
- Most devices (88%) approved for ages ≥18, considered pediatric by FDA.
- Trials predominantly used non-randomized, open-label designs with surrogate endpoints.
- 84% of devices lacked studies in patients under 18.
- Postmarketing studies were mandated for 76% of devices, but only 18% required pediatric patients.
Conclusions:
- High-risk pediatric devices are often approved based on adult trial data.
- Limited exposure of pediatric patients to devices before market availability.
- Few postmarketing studies necessitate further pediatric investigation.
Background:
Medical devices can be useful in a variety of diseases, but few devices have been specifically approved for use in children. The 2007 Pediatric Medical Device Safety and Improvement Act was passed to stimulate pediatric device development. The current state of trial evidence underpinning the approval of pediatric devices remains poorly described.
Methods:
We identified all high-risk (ie, class III) devices approved through the premarket approval or humanitarian device exemption pathways for therapeutic use in children between 2008 and 2011. We collected key information on clinical trial design (randomization, blinding, controls, and types of end points) as well as age distribution of trial participants. We also identified US Food and Drug Administration (FDA)-mandated postmarketing trials.
Results:
Twenty-two devices were approved for use in children via the premarket approval pathway and 3 via the humanitarian device exemption pathway. Twenty-two (88%) qualified as pediatric despite minimum approval ages of ≥18 years (the FDA Center for Devices and Radiologic Health considers patients 18-21 years old as pediatric). Most devices were approved on the basis of nonrandomized (59%), open-label (68%) studies with surrogate effectiveness end points (86%). Overall, 21 (84%) devices were not studied in any patients <18 years of age. Postmarketing studies were mandated by the FDA for 19 (76%) devices, although only 3 (18%) required enrollment of pediatric patients.
Conclusions:
Most high-risk pediatric devices are approved on the basis of trials in patients ≥18 years old, with few pediatric patients exposed to the devices before market availability. Few postmarketing studies require additional study in pediatric patients.
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