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Pediatric Medical Devices | FDA

    https://www.fda.gov/medical-devices/products-and-medical-procedures/pediatric-medical-devices
    The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines pediatric patients as persons aged 21 or younger at the time of their diagnosis or treatment. Pediatric subpopulations are...

Public Law 110–85 110th Congress An Act

    https://www.congress.gov/110/plaws/publ85/PLAW-110publ85.pdf
    TITLE III—PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007 Sec. 301. Short title. Sec. 302. Tracking pediatric device approvals. Sec. 303. …

Fact Sheet: Pediatric provisions in the Food and Drug …

    https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/fact-sheet-pediatric-provisions-food-and-drug-administration-safety-and-innovation-act-fdasia
    FDASIA renews and strengthens three essential laws to improve the safety and effectiveness of pediatric drugs, biological products, and medical devices used in …

S.830 - Pediatric Medical Device Safety and …

    https://www.congress.gov/bill/110th-congress/senate-bill/830
    Pediatric Medical Device Safety and Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for the approval of a …

Pediatric Safety | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/science-research/pediatrics/pediatric-safety
    The Office of Pediatric Therapeutics Pharmacovigilance Team implements the mandated pediatric-focused safety reviews of drugs, biologics, vaccines, and …

FDAAA Implementation – Highlights One Year After …

    https://www.fda.gov/regulatory-information/food-and-drug-administration-amendments-act-fdaaa-2007/fdaaa-implementation-highlights-one-year-after-enactment
    The act, primarily Title IX, also provides FDA with additional requirements, authorities, and resources with regard to both pre- and postmarket drug safety. The statute contains …

AAP brings need for pediatric medical devices to forefront

    https://publications.aap.org/aapnews/news/6524/AAP-brings-need-for-pediatric-medical-devices-to
    The AAP-championed Pediatric Medical Device Safety and Improvement Act of 2007 assisted development by improving device tracking, creating an incentive for …

S.830 - Pediatric Medical Device Safety and …

    https://www.congress.gov/bill/110th-congress/senate-bill/830/text
    “(2) L ONGER STUDIES FOR PEDIATRIC DEVICES.—The Secretary may by order require a prospective surveillance period of more than 36 months with respect to …

Best Pharmaceuticals for Children Act and Pediatric …

    https://www.fda.gov/science-research/pediatrics/best-pharmaceuticals-children-act-and-pediatric-research-equity-act
    The Food and Drug Administration Safety and Innovation Act (FDASIA), enacted in 2012, requires the Secretary of Health and Human Services to report on the …

S. 830 (110 th ): Pediatric Medical Device Safety and …

    https://www.govtrack.us/congress/bills/110/s830/summary
    Pediatric Medical Device Safety and Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for the approval of a …



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