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Help Keep a Sick Child Safe: Learn How to Use a …

    https://www.fda.gov/consumers/consumer-updates/help-keep-sick-child-safe-learn-how-use-hospital-crib
    Regulating Pediatric Medical Cribs and Medical Bassinets for Safety Just as equipment including wheelchairs and walkers are considered medical devices and are regulated by FDA, so too are...

Current FDA regulation allows pediatric medical cribs …

    https://www.fda.gov/medical-devices/products-and-medical-procedures/information-pediatric-medical-cribs-and-medical-bassinets-used-homes-child-care-settings-and
    The FDA issued a proposed rule on October 8, 2015, proposing new safety requirements for medical cribs and bassinets used in the treatment and care of pediatric patients which …

FDA Issues New Rule on Pediatric Medical Cribs

    https://www.fda.gov/files/science%20&%20research/published/FDA-issues-new-rule-on-pediatric-medical-cribs--medical-bassinets.pdf
    FDA regulation has allowed pediatric medical cribs used in health care settings to have drop-side rails to make it easier to provide medical care to sick children. The new rule …

Safe Sleep – Cribs and Infant Products | CPSC.gov

    https://www.cpsc.gov/SafeSleep
    Cribs Standards & Guidance CPSC Urges Parents/Caregivers to Use Products that Are Safe for Sleep; Check Baby’s Sleep Space for Suffocation Hazards; Most Nursery …

eCFR :: 21 CFR 880.5140 -- Pediatric medical crib.

    https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-880/subpart-F/section-880.5140
    § 880.5140 Pediatric medical crib. ( a) Identification. A pediatric medical crib is a prescription device intended for medical purposes for use with a pediatric patient that …

CFR - Code of Federal Regulations Title 21 - Food and …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=880.5140
    A pediatric medical crib is a prescription device intended for medical purposes for use with a pediatric patient that consists of an open crib, fixed end rails, …

AAP News FDA Updates | FDA - U.S. Food and Drug …

    https://www.fda.gov/science-research/pediatrics/aap-news-fda-updates
    Jan 27, 2023

Recognized Consensus Standards - accessdata.fda.gov

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=41989
    ASTM F1169-19. Standard Consumer Safety Specification for Full-Size Baby Cribs. Scope/Abstract. 1.1 This consumer safety specification establishes …

General Hospital and Personal Use Devices: Renaming of …

    https://www.federalregister.gov/documents/2016/12/19/2016-30193/general-hospital-and-personal-use-devices-renaming-of-pediatric-hospital-bed-classification-and
    Pediatric medical cribs that meet the definition of a device in section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) ( 21 U.S.C. 321 (h)) …

General Hospital and Personal Use Devices: …

    https://www.fda.gov/media/102404/download
    the classification regulation from “pediatric hospital bed” to “pediatric medical crib,” and place medical bassinets, previously under the pediatric hospital beds classification …



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