21 CFR 880.5690

(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.

[91 FR 38508, June 26, 2026]