Small Sleep Sacks, Big Compliance Lessons: What FDA’s Happiest Baby Warning Letter Means for Device Manufacturers June 23, 2026 By Jennifer D. Newberger —

https://www.thefdalawblog.com/2026/06/small-sleep-sacks-big-compliance-lessons-what-fdas-happiest-baby-warning-letter-means-for-device-manufacturers/?utm_source=rss&utm_medium=rss&utm_campaign=small-sleep-sacks-big-compliance-lessons-what-fdas-happiest-baby-warning-letter-means-for-device-manufacturers On June 15, 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Happiest Baby, Inc., the manufacturer of the SNOO Smart Sleeper bassinet system, following a July 2025 inspection of the company’s Los Angeles facility. The Warning Letter highlights several key points related to complaint handling, premarket notification requirements, field correction reporting, design changes, and unauthorized changes to the device’s intended use environment, with important lessons for device manufacturers of all sizes.