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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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  To search for Manufacturer beginning with a specific letter, select that letter

SNOO Smart Sleeper

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Study Status Ongoing
522 Number / Requirement Number PS230001 / PSS001
Date Original Plan Accepted 07/27/2023
Study Name SNOO Smart Sleeper
Device Name Snoo smart sleeper
Root Document Number DEN210039 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs
Detailed Study Protocol Parameters
Study Objectives Non-interventional, prospective observational and descriptive active surveillance study.
Postmarket surveillance study of infants who use SNOO and are at high risk of SIDS/SUID to determine the rates of serious injury and death, including from inadequate securement or inadequate positioning of the infant.
Study Population Infants 0-6 months who used the SNOO during the first 6 months
Sample Size Number of subjects: 1,000
Sites location: Users/caregivers homes that rent or purchase the SNOO.
Key Study Endpoints Safety Endpoints
Primary: Incidence of respondent-reported device-related serious injury and/or device-related death.
Secondary: Infant age during SNOO use. Degree of SNOO use. Weaning rationale.
Effectiveness Endpoints
Primary: Any instance of device-related serious injury (#/%), which is defined as injury or illness that:
(1) Is life-threatening;
(2) Results in permanent impairment of a body function or permanent damage to a body structure, or
(3) Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
Any instance of device-related infant death (#/%)
Secondary: Infant age at the start of SNOO use - Infant age at the end of SNOO use.
Frequency of SNOO use [All of the time (>90%); Most of the time (50-90%); Some of the time (10%-50%); None of the time (<10%)
Reason for ending SNOO use.
Follow-up Visits and Length of Follow-up Prospective enrollment at 1 month following SNOO ship date with 6- month follow up questionnaire (7 months post-ship date) for data collection of study endpoints

SNOO Smart Sleeper Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 09/30/2023 10/02/2023 Overdue/Received
1 year report 03/30/2024 03/29/2024 On Time
18 month report 09/28/2024    
2 year report 03/30/2025    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources