Natures Pillows, Inc. and Top Dog Direct, LLC

The United States Food and Drug Administration (FDA) has learned that your firm is offering for sale in the United States the Clean Zone CPAP Sanitizer without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device 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 to affect the structure or any function of the body.

FDA has reviewed the labeling for your devices on your website, http://www.cleanzonenow.com (last visited June 04, 2024) and determined that the Clean Zone CPAP Sanitizer is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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) for the device as described and marketed. The Clean Zone CPAP Sanitizer is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered into interstate commerce for commercial distribution this device without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(1). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency (21 CFR 807.81(b)(1))

On your firm’s website, your device is described as using activated oxygen to disinfect and sanitize Continuous Positive Airway Pressure (CPAP) therapy devices and CPAP accessories, and your website includes the following claim:

“Clean Zone™ CPAP Sanitizer can produce activated oxygen quickly to reach every corner of your CPAP machine, tube and mask, killing 99% of germs and bacteria. Very safe and convenient, the optimized design enables faster generation of activated oxygen during start-up and faster dissipation after clean.”

On May 26, 2021, the FDA sent a letter to NATURES PILLOWS, INC. AND TOP DOG DIRECT, LLC, stating that the Clean Zone CPAP Sanitizer appears to meet the definition of a device under the FD&C Act and that it does not appear to be a Class I exempt medical device. On June 24, 2021, Counsel for Top Dog Direct, Inc., responded to FDA, asserting that the device is exempt from premarket notification requirements as a Class I device under 21 CFR 880.6890, General purpose disinfectants. Specifically, the response stated that “CPAP device masks only contact the intact skin of the user and, therefore, would be considered noncritical devices.”

Your response is inadequate because it does not accurately reflect the nature of the CPAP device accessories intended to be disinfected and sanitized by the Clean Zone CPAP Sanitizer. Your products are medical device accessories because, as evidenced by the labeling, they are intended to support, supplement, and/or augment the performance of one or more parent devices. Specifically, as described above, the labeling for your products indicates they are intended to support the performance of CPAP therapy devices and accessories by disinfecting them. CPAP therapy devices and accessories are considered to be semi-critical devices which indirectly contact the user’s respiratory tract via the gas pathway. Ozone treatment of these CPAP therapy devices and accessories presents risks to patient safety and device performance, e.g., adverse tissue reaction, patient infection, CPAP device/accessory malfunction or physical damage, that need to be addressed through special controls, such as material compatibility, biocompatibility, microbial reduction efficacy testing, etc. Therefore, the exemption from premarket notification requirements under 21 CFR 880.6890 does not apply to this device.

The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Our office requests that NATURES PILLOWS, INC. AND TOP DOG DIRECT, LLC cease any activities that result in the misbranding or adulteration of the Clean Zone CPAP Sanitizer, such as the commercial distribution of the device for the uses discussed above.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent by email to: CDRHWarningLetterResponses@fda.hhs.gov or by mail to:

Food and Drug Administration Center for Devices and Radiological Health Office of Regulatory Programs Division of Regulatory Programs 2: Establishment Support Regulatory Inspections and Audits Team White Oak Building 66 10903 New Hampshire Ave. Silver Spring, MD 20993

Refer to the identification number CPT2001400 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Dr. BiFeng Qian at: bifeng.qian@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.