Natures Pillows, Inc. and Top Dog Direct, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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.

Passage 2

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).

Passage 3

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.