FDA WARNING_LETTER - Blountys, LLC - June 14, 2010

The FDA issued a Warning Letter to Blountys, LLC regarding their NightForm Infant Positioning Mattress. The FDA found the firm was marketing the device in the U.S. without required marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

A premarket notification (510(k)) for the device (K041996) was cleared on August 3, 2004, for healthy infants 0-9 months to aid in preventing deformational plagiocephaly. However, the FDA did not clear the device for Sudden Infant Death Syndrome (SIDS) prevention.

A review of Blountys' website on June 14, 2010, revealed the device was promoted to address the "dual risk of SIDS and of sleep-related skull flattening." This promotion for SIDS constitutes a significant change in intended use, requiring a new 510(k) submission (21 CFR 807.81(a)(ii)). Consequently, the device is adulterated under section 501(f)(1)(B) of the Act because there is no approved PMA or IDE.

Furthermore, the device is misbranded under section 502(o) for failure to submit a notification regarding the change in intended use (21 U.S.C. 360(k) and 21 CFR 807.8