Information for Manufacturers of Baby Products
Some manufacturers may not be aware that marketing a baby product with claims to cure, treat, or prevent a disease or condition, including Sudden Infant Death Syndrome (SIDS), makes their product a medical device. Medical devices are regulated by the FDA.
The FDA has never cleared or approved a baby product to prevent or reduce the risk of SIDS. The agency is not aware of any scientific studies supporting the safety and effectiveness of a baby product to prevent or reduce the risk of SIDS.
To get FDA approval or clearance to market a medical device, the manufacturer must prove:
- there is reasonable assurance of the device’s safety and effectiveness; or
- the medical device is "substantially equivalent" to a device already legally marketed for the same use.
For an overview of medical devices and some basic information about device regulation, visit Overview of Medical Devices and Their Regulatory Pathways.
Recommendations for Manufacturers
The FDA recommends that you review your current labeling, packaging, and advertising for any direct or implied claims to cure, treat, or prevent a disease or condition, including SIDS.
If your labeling, packaging, or advertising (including print and online) contains claims to prevent or reduce the risk of SIDS, you are in violation of the Federal Food, Drug, and Cosmetic Act.
In order to comply with FDA regulations you must immediately:
- Stop marketing your products with these claims until you receive FDA clearance or approval; or
- Change your labeling, packaging, or advertising to remove all medical claims and ensure your products are not marketed as medical devices.
If you are a manufacturer and you are not sure if your baby product is a medical device, please check Device Advice: Device Regulation and Guidance.
If you have questions about what to do in order to seek FDA approval or clearance for your medical device, contact the Division of Small Manufacturers, International and Consumer Assistance at 1-800-638-2041 or via email at email@example.com.