---
kind: "section"
citation: "21 C.F.R. § 880.5690"
title: "21"
number: "880.5690"
heading: "Infant supine sleep system."
url: "https://uscodex.org/cfr/21/880.5690"
---

# §880.5690. Infant supine sleep system.

- (a) **Identification.** An infant supine sleep system is a device intended to facilitate a supine position during sleep for use in infants that are not yet able to roll over consistently. Infants placed in a supine sleep position are at lower risk of sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID).
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Premarket clinical information and, as determined by FDA, postmarket surveillance data acquired under anticipated conditions of use must be collected to fulfill the following:
    - (i) Demonstrate that the device holds the infant on the back;
    - (ii) Provide data on adverse events (including deaths and injuries) and malfunctions to demonstrate the device can be safely used in the intended use population; and
    - (iii) Provide data to demonstrate that use of the device does not increase the rate of SIDS/SUID in the intended use population.
  - (2) Human factors testing must demonstrate that the user can safely and correctly use the device.
  - (3) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be conducted:
    - (i) Testing to ensure the mechanical and structural stability of the device and demonstrate that the device does not present a tipping hazard due to mechanical failures; and
    - (ii) Material compatibility testing to demonstrate that the cleaning instructions provided by the manufacturer do not cause crazing, cracking, or deterioration of the device.
  - (5) Labeling must include:
    - (i) Unless clinical performance data demonstrates that it can be removed or modified, a prominent warning that the device has not been demonstrated to reduce the risk of SIDS/SUID. Such warning must appear prominently on all labeling;
    - (ii) A summary of available clinical information with the device, including a discussion of adverse events;
    - (iii) A warning that the device is only indicated for use with infants who cannot consistently roll over;
    - (iv) Instructions to ensure proper fit;
    - (v) Instructions for cleaning the device; and
    - (vi) **Information regarding safe sleep practices to ensure the safe use of the device, including—**
      - (A) Recommendations for safe sleep environments; and
      - (B) **The level of supervision necessary to monitor a sleeping infant.**

## Notes

### Amendments

[91 FR 38508, June 26, 2026]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

### Amendments

[91 FR 38508, June 26, 2026]