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Pediatric Medical Devices | FDA

    https://www.fda.gov/medical-devices/products-and-medical-procedures/pediatric-medical-devices
    Pediatric medical devices treat or diagnose diseases and conditions from birth through age 21. The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines pediatric patients as persons aged 21...

Pediatrics | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/science-research/science-and-research-special-topics/pediatrics
    Through federal laws, pediatric research, and child-focused initiatives, the FDA supports the development and availability of drugs, biologics, and medical devices …

Providing Information about Pediatric Uses of Medical …

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-information-about-pediatric-uses-medical-devices
    Section 515A requires submitters to FDA of premarket approval applications (PMAs), supplements to PMAs, humanitarian device exemptions (HDEs), and product …

Solving Unmet Needs With Innovative Pediatric Medical …

    https://www.embs.org/pulse/articles/solving-unmet-needs-with-innovative-pediatric-medical-devices/
    In the last decade, only 24% of class III life-saving devices approved by the U.S. Food and Drug Administration (FDA) were for pediatric use—and most of those …



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