# 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
> **Food and Drug Administration** · Final rule. · Published 2016-12-19 · Effective 2017-01-18 · 81 FR 91731
## Document
- **Document number:** 2016-30193
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 91731
- **CFR reference:** 21 CFR 880
- **Publication date:** 2016-12-19
- **Effective date:** 2017-01-18
- **HHS docket:** Docket No. FDA-2015-N-0701
## Abstract

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 both devices to be exempt from premarket notification and use of the device in traditional health care settings and permits prescription use of pediatric medical cribs and bassinets outside of traditional health care settings.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/12/19/2016-30193/general-hospital-and-personal-use-devices-renaming-of-pediatric-hospital-bed-classification-and)
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