September 29, 2010
CEO or President
Infant Positioner Manufacturer.
123 Main St
Subject: Devices Can Create Risk of Suffocation
Dear Sir or Madam:
The purpose of this letter is to inform you that the U.S. Food and Drug Administration (FDA) has new information indicating that there is a risk of suffocation associated with the use of infant sleep positioners, and of the actions we are requesting of you as a medical device manufacturer.
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. Any medical device marketed with SIDS claims is not legally marketed without prior FDA review and clearance.
In the past, the FDA cleared infant sleep positioners to treat or prevent GERD and flat head syndrome. The FDA has never cleared an infant sleep positioner with a claim to prevent or reduce the risk of SIDS. In light of new safety data, FDA is not aware of evidence that any benefits of these devices outweigh the risk of suffocation associated with any use.
FDA is contacting manufacturers of infant sleep positioners with 510(k) clearances and requesting you submit within 30 days of the date of this letter, safety and effectiveness data, which clearly addresses the benefit of your product in light of the risk of suffocation. The FDA is requesting all device manufacturers of infant sleep positioners to stop marketing their devices while it reviews your submitted safety and effectiveness data. Your data must show that the benefits associated with the use of your device outweigh the risk of suffocation.
FDA is also warning consumers to stop using these products due to the risk of suffocation.
If you have any questions regarding your 510(k) clearance, including the data to submit, please contact Richard Chapman, General Hospital Devices Branch, Center for Devices and Radiological Health, at 301-796-2585.
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: email@example.com for additional information.
Jeffrey E. Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration