The majority of medical and surgical devices used to treat children are not cleared by the Food and Drug Administration for use in pediatric populations, according to a new report from the American Academy of Pediatrics.
Here are three things to know.
- Various economic and market barriers hinder the development of medical and surgical devices for children, according to the report.
- The large, unmet clinical need for devices to diagnose and treat children led to the widespread practice of using devices for uses not out rightly approved by the FDA.
- While the FDA does not regulate devices for off-label uses in children, the practice is legal and the agency views it as the practicing of medicine. AAP calls off-label use "a necessary and appropriate part of care", according to the report. Without off-label use, some children could be left with no therapeutic options.
- Unlike the drug development process, there is no law requiring companies to study medical devices in pediatric populations during the device development process.
To view the full report, along with AAP's recommendations for how to safely navigate off-label use, click here.
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