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Summary: General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet (Proposed Rule)

Summary: General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet (Proposed Rule)

The Food and Drug Administration (FDA) is proposing to rename pediatric hospital beds as pediatric medical cribs and establish special controls for these devices. FDA is also proposing to establish a separate classification regulation for medical bassinets, previously under the pediatric hospital bed classification regulation, as a class II (special controls) device. The proposed regulation for both pediatric medical cribs and medical bassinets would also include the Consumer Product Safety Commission's (CPSC) mattress flammability standards for the mattresses intended for use with these devices. In addition, this proposed rule would require prescription use of pediatric medical cribs and bassinets.

Regulatory Impact Analysis

General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet (Proposed Rule) (PDF - 37KB)

Federal Register: 80 FR 60809, October 8, 2015

Docket: FDA-2015-N-0701