ArticlePediatrics2014
Postmarketing trials and pediatric device approvals.
Article in Pediatrics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
26 citing papers in PubMed, 65 citations in OpenAlex.
- FDA-Regulated AI-Enabled Medical Devices With Pediatric Indications.JAMA network open · 2026Article
- Describing Inconsistencies in Pediatric Labeling of Medical Devices.JAMA network open · 2025Article
- Bridging the Gap in FDA Approval for Pediatric Neuromodulation Devices.Children (Basel, Switzerland) · 2025Review
- The newborn delivery room of tomorrow: emerging and future technologies.Pediatric research · 2024Review
- Barriers to and facilitators of paediatric medical device innovation: a scoping review protocol.BMJ open · 2024Article
- Minimal Access in Pediatric Surgery: An Overview on Progress towards Dedicated Instrument Developments and Anesthesiologic Advances to Enhance Safe Completion of Procedures.Children (Basel, Switzerland) · 2024Article
- Economic evaluations of medical devices in paediatrics: a systematic review and a quality appraisal of the literature.Cost effectiveness and resource allocation : C/E · 2024Review
- Evidence from clinical trials on high-risk medical devices in children: a scoping review.Pediatric research · 2024Article
- The state and future of pediatric research-an introductory overview : The state and future of pediatric research series.Pediatric research · 2023Article
- Technical, Ethical, Legal, and Societal Challenges With Digital Twin Systems for the Management of Chronic Diseases in Children and Young People.Journal of medical Internet research · 2022Review
- Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices).European heart journal. Quality of care & clinical outcomes · 2022Article
- Advancing pediatric medical device development via non-dilutive NIH SBIR/STTR grant funding.Journal of pediatric surgery · 2021Article
- Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices).EFORT open reviews · 2021Review
- Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications.JAMA network open · 2021Article
- Global Regulatory Review Needed for Cochlear Implants: A Call for FDA Leadership.Maternal and child health journal · 2020Article
- Rigorous and consistent evaluation of diagnostic tests in children: another unmet need.Pediatric research · 2020Article
- Regulator Loss Functions and Hierarchical Modeling for Safety Decision Making.Medical decision making : an international journal of the Society for Medical Decision Making · 2017Article
- Medical Devices and Adolescents: Points to Consider.JAMA pediatrics · 2016Article
- Proceedings from Heart Rhythm Society's emerging technologies forum, Boston, MA, May 12, 2015.Heart rhythm · 2016Article
- Customizable orthopaedic oncology implants: one institution's experience with meeting current IRB and FDA requirements.SpringerPlus · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundMedical 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.
methodsWe 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.
resultsTwenty-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.
conclusionsMost 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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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.