Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
JUN 23 2010
Via United Parcel Service
6312 NW 99th Avenue
Doral, Florida 33178
RE: NightForm Infant Positioning Mattress
Dear Mr. Blount:
Refer to GEN0900704 when replying to this letter.
The Food and Drug Administration (FDA) has learned that your firm is marketing the NightForm Infant Positioning Mattress in the United States (U.S.) without the required marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The NightForm Infant Positioning Mattress is a device within the meaning of section 201 (h) of the Act Because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body, 21 U.S.C. 321(h). The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already marketed in this country for which approval is not required.
A review of our records indicate that we cleared a premarket notification (510(k) for this device, K041996, on August 3, 2004, with an indication "for healthy infants 0-9 months to aid in the prevention of skull deformities that can rise from consistent back-sleeping postures, namely the condition known as deformational (or positional) plagiocephaly." We did not clear this device for use in the prevention of sudden infant death syndrome (SIDS).
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your website (most recently on June 14, 2010), located at http://www.blountys.com/Nightform-Infant-Positioning-Matress-Pink-p/nf1001pink.htm for the NightForm Infant Positioning Mattress. According to your website:
" ...NightForm Infant Positioning Mattress... is designed to address the dual risk of SlDS and of sleep-related skull flattening (deformational plagiocephaly)...
Promotion of this device for SIDS causes a significant change in the intended use of the device that requires the submission of a new 510(k). 21 CFR 807.81(a)(ii). Because of the SIDS claims, the device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B). because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). This device is also misbranded under section 502(o) of the Act 21 U.S.C. 352(o), because you did not submit to FDA a notification respecting the changes to the intended use of the device, as required by section 510(k), 21 U.S.C. 360(k), and 21 CFR 807.81 (a)(3)(ii).
The device is also misbranded under section 502(a) of the Act, 21 U.S.C. 352(a), in that the labeling of the device, namely your website located at www.blounty.com contains statements that are misleading in accordance with 21 CFR 807.97, because such statements create an impression of official approval of a device due to clearance of a premarket notification submission. Specifically, the labeling states, with respect to the NightForm Infant Positioning Mattress
"Is it safe to use?
... It is the only FDA-approved infant sleep positioner product on the market today."
''How is NightForm different from other sleep wedges on the market?
...It has been clinically tested and it is approved by the FDA as a regulated medical device. No other device can claim these medical qualifications."
This device was not approved by the FDA, but was determined to be substantially equivalent within the meaning of section 513(i)(1)(A) of the Act, 21 U.S.C. 360c(i)(1)(A).
This device is also misbranded under section 502(o) of the Act 21 U.S.C. 352(o), because it was manufactured, prepared, propagated, compounded, or processed In an establishment not duly registered under section 510 of the Act, 21 U.S.C. 360; and it was not included in a list as required by 510(j) of the Act, 21 U.S.C. 360(j).
The Office of Compliance requests that Blountys LLC immediately cease marketing the NightForm Infant Positioning Mattress for unapproved/uncleared uses such as those described above. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties.
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing what steps you have taken to correct the problem and how you plan to prevent this from happening again. Please list all promotional materials for NightForm Infant Positioning Mattress containing claims for unapproved/uncleared uses such as those described above, and explain your plan for discontinuing such claims. Please direct your response to George Kroehling at the Food and Drug Administration. 10903 New Hampshire Avenue, W066-3512, Silver Spring, MD 20993 or via facsimile at (301) 847-8137. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that NightForm Infant Positioning Mattress complies with each applicable requirement of the Act and FDA implementing regulations.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and
10162 Northwest 87th Court
Miami, FL 33178