September 29, 2010
CEO or President
Infant Positioner Manufacturer.
123 Main St
Subject: Devices Can Create Risk of Suffocation
Dear Sir or Madam:
The Food and Drug Administration (FDA) has learned that your firm is marketing an infant positioner product that appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act. We have conducted a review of our files, and have been unable to identify any Food and Drug Administration (FDA) clearance number for the [NAME OF THE DEVICE].
You are advised that marketing a device in the United States (U.S.) without marketing clearance or approval is a violation of the Federal Food, Drug, and Cosmetic Act (the Act), in that such device is misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by sections 510(k) of the Act, 21 U.S.C. 360(k). The FDA will take appropriate actions against manufacturers who fail to promptly take these steps.
You must stop marketing and distributing your device immediately.
The FDA and the U.S. Consumer Product Safety Commission are aware of 12 infant deaths in the past 13 years associated with the use of infant sleep positioners. The device may entrap infants and cause suffocation. Infants placed on their sides in sleep positioning devices are more likely to flip into a face down position rather than onto their backs because their backs are pressed against the side of the infant sleep positioning product. Even if placed properly on their backs, infants may be able to scoot up or downward on the sleep positioning device and risk becoming entrapped and suffocate between the device and the crib side or bassinet.
Many infant sleep positioners include medical claims that the device prevents Sudden Infant Death Syndrome (SIDS), prevents plagiocephaly (including flat head syndrome), or relieves the symptoms of gastroesophageal reflux disease (GERD). Infant sleep positioners are medical devices when such medical claims are made and subject to FDA regulation, including the requirement of FDA clearance of a 510(k) application.
In light of the suffocation risk and the lack of evidence of any benefits, we are warning consumers to stop using these products.
If you wish to pursue marketing of such product in the future, you must submit a 510(k) application to FDA, and provide safety and effectiveness data, substantiating the medical claims you propose in the context of the established suffocation risk associated with infant positioner devices.
If you are unsure whether your product is a medical device, please consult Device Advice: Device Regulation and Guidance. If you have questions about what you should do if you do not have a 510(k) clearance or other questions, please contact Lashanda Long-Croal. General Hospital Device Branch, Office of Compliance, Center for Devices and Radiological Health, at 301-796-5770.
Manufacturers of medical devices are subject to the requirements of the Medical Device Reporting (MDR) regulation and may have an obligation to submit MDRs to FDA for device related deaths, serious injury and malfunction events. You can find guidance about the MDR regulation at: http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. You may also contact the Reporting Systems Monitoring Branch at: firstname.lastname@example.org for additional information.
Jeffrey E. Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration