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Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With
Samuel J Lee1, Lauren Cho2, Eyal Klang2
1Hasso Plattner Institute for Digital Health at Mount Sinai, Icahn School of Medicine at Mount Sinai, New York, New York.
Insights
High-risk medical devices for children are scarce and lack diversity, limiting treatment options. This study quantifies this gap, identifying areas needing pediatric device innovation.
Area of Science:
- Biomedical Engineering
- Pediatric Medical Devices
- Regulatory Science
Background:
- Medical device companies seek US Food and Drug Administration (FDA) premarket approval (PMA) for high-risk devices.
- Pediatric indications for devices using the PMA pathway are not well-characterized.
Purpose of the Study:
- To identify and characterize high-risk medical devices with pediatric age indications from PMA statements.
- To analyze the distribution and diversity of these pediatric devices.
Main Methods:
- Cross-sectional study of FDA PMA statements (as of February 2020).
- Manual annotation of age indications in approval statements.
- Querying device metadata including product codes and approval dates.
Main Results:
- 102 of 149 unique devices had pediatric indications.
- Significant increase in device availability for ages 17-18 years.
- Many pediatric devices were approved for limited age ranges (18-21 years).
Conclusions:
- A notable gap exists in the quantity and diversity of high-risk pediatric devices.
- This scarcity may limit therapeutic options for children.
- Findings can inform future pediatric device development and identify areas of need.
Importance:
Medical device companies submit premarket approval (PMA) statements to the US Food and Drug Administration (FDA) for approval of the highest-risk class of devices. Devices indicated for the pediatric population that use the PMA pathway have not been well characterized or analyzed.
Objective:
To identify and characterize high-risk devices with pediatric age indications derived from PMA statements.
Design, Setting, And Participants:
In this cross-sectional study of PMA statements, those statements containing the words indicated or intended for medical devices listed in the FDA PMA database as of February 2020 were retrieved. Age indications were manually annotated in these approval statements via PubAnnotation. Based on the PMA identification from the PMA statements, device metadata including product codes, regulation numbers, advisory panels, and approval dates were queried.
Main Outcomes And Measures:
The main outcome was discernment of the distribution of devices indicated for the pediatric population (neonate, infant, child, and adolescent). Secondary measures included outlining the clinical specialties, device types, and lag time between the initial approval date and the first date of an approval statement with a pediatric indication for generic device categories.
Results:
A total of 297 documents for 149 unique devices were analyzed. Based on the manual age annotations, 102 devices with a pediatric indication, 10 with a neonate age indication, 32 with an infant age indication, 60 with a child age indication, and 94 with an adolescent age indication were identified. For indications for patients from age 17 to 18 years, the number of devices available nearly doubled from 42 devices to 81 devices. Although more than half of the surveyed devices had a pediatric age indication, many were available only for a limited range of the pediatric population (age 18-21 years). For indications for patients from age 0 to 17 years, the mean (SD) number of clinical specialties at each age was 7.27 (1.4), and 12 clinical specialties were represented from ages 18 to 21 years.
Conclusions And Relevance:
In this cross-sectional study on device PMA statements, a gap was identified in both quantity and diversity of high-risk devices indicated for the pediatric population. Because the current scarcity of pediatric devices may limit therapeutic possibilities for children, this study represents a step toward quantifying this scarcity and identifying clinical specialties with the greatest need for pediatric device innovation and may help inform future device development efforts.