The Food and Drug Administration (FDA) is issuing a final rule to rename pediatric hospital beds as pediatric medical cribs and establish special controls for these devices. FDA is also establishing a separate classification regulation for medical bassinets, previously under the pediatric hospital bed classification regulation, as a class II (special controls) device. In addition, this rule continues to allow use of both devices in traditional health care settings and permits prescription use of pediatric medical cribs and bassinets outside of traditional health care settings.
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 (Final Rule) RIA
Federal Register: 81 FR 91731, December 19, 2016