JAMA Netw Open. 2025 Dec 1;8(12):e2546517. doi: 10.1001/jamanetworkopen.2025.46517.
ABSTRACT
IMPORTANCE: The US Food and Drug Administration (FDA) has recommended, but not required, age ranges for pediatric age labeling in devices, despite regulation existing for drugs, and this policy perpetuates off-label use of devices and creates several issues in practice for safety and monitoring. Proper device labeling is an important regulatory component that impacts risk stratification, clinical use, marketing, and reimbursement.
OBJECTIVE: To evaluate the variability in pediatric medical device age labeling among all pediatric class III devices approved by the FDA from 2008 to 2017 and their adherence to nonbinding FDA age range recommendations, and to review the device type, clinical use, and whether the pediatric population was included in clinical trials.
DESIGN, SETTING, AND PARTICIPANTS: This retrospective cross-sectional study reviewed data from public databases to understand pediatric age labeling practices. Data included in the 2008 to 2017 Reports to Congress: Premarket Approval of Pediatric Uses of Devices were reviewed in 2022. Additional data were extracted from the FDA Databases. Two physicians independently reviewed the data and assigned clinical descriptors to each device. Descriptive analysis was performed.
EXPOSURE: Device approval by the FDA from 2008 to 2017.
MAIN OUTCOMES AND MEASURES: The primary outcomes were whether approved devices had age labeling, whether they described the approved pediatric population, and whether pediatric populations were included in clinical studies of the devices. Pairwise comparison was done with Student t test and P < .05 to indicate statistically significant differences.
RESULTS: Of 101 unique devices, 26 (25.7%) did not include any specific age ranges and among the remaining 75 devices, 51 (50.5%) were not indicated for patients younger than 18 years. There was significant variation in age labeling, with only 4 devices using fully structured age ranges (eg, 2 to 17 years). Only 8 (7.9%) devices used the FDA recommended pediatric age ranges. The review of clinical trials evaluating device safety and efficacy revealed that 60 (59.4%) included pediatric patients (aged 0 to <22 years); however, only 33 (32.7%) included patients younger than 18 years. In contrast, the Indications For Use statements for the same devices indicate 52 (51.5%) did not include any specific age ranges and 29 (28.7%) were indicated for adults 18 years or older.
CONCLUSIONS AND RELEVANCE: In this cross-sectional analysis of devices included the 2008 to 2017 Reports to Congress, most high-risk devices were not evaluated or specifically indicated for children younger than 18 years. This poses substantial problems for clinical use, reimbursement, research, and policy evaluation. To address this gap, the FDA should establish pediatric labeling requirements that consider age and other relevant factors.
PMID:41343216 | DOI:10.1001/jamanetworkopen.2025.46517
