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Selected passages from the FDA letter

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

Passage 1

these products are 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).

Passage 2

These products are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

Passage 3

these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because their labeling is false or misleading. FDA registration of a device establishment or assignment of a registration number does not denote FDA approval of the establishment or the device. Thus, references to a firm’s establishment registration and registration number that create an impression of official FDA approval, clearance, authorization, certification, endorsement or other evaluation of the establishment or the devices are misleading and constitute misbranding. See 21 CFR 807.39.

Passage 4

Unauthorized display of what appears to be FDA’s logo***2*** above an illustration of a mask, on the top left corner of your website.

Passage 5

Displaying a “Certification of Registration” (KN95 Dust Mask Certification) issued by “HealReg Service Inc.” alongside KN95 Dust Mask product information. The Certification “certifies that Zhongshan Dongfeng HuangShang Electronic Factory…has completed the FDA Establishment Registration and Device Listing with the US Food & Drug Administration…” and incorporates unauthorized use of the FDA logo***2***.

Passage 6

Displaying a “Certification of Registration” (Medical Grade/Surgical Mask Certification) issued by “Shenzhen SHT Testing Technology Co. Ltd.” alongside Medical Grade/Surgical Mask product information. The Certification “certifies that Shenzhen Keyu Electronic Material Trading Co., Ltd…was registered with US Food & Drug Administration…pursuit [sic] to the Code of Federal Regulations 21 CFR 807…” and incorporates unauthorized use of the FDA logo***2***.

Passage 7

Displaying a “Certification of Registration” (Disease Prevention Mask for Child Certification) alongside the Disease Prevention Mask for Child product information. The Certification “certifies that Huizhou Shuangzuan Protection Technology Co., Ltd…has completed the FDA Establishment Registration and Device Listing with the US Food & Drug.” Although some of the small text is blurry, the Certification incorporates unauthorized use of the FDA logo***2***.

Passage 8

Taken together, display of screenshots from FDA’s Establishment Registration & Device Listing Database and the KN95 Dust Mask Certification, bearing the FDA logo, positioned near images of and information about the product are misleading because they imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the KN95 Dust Mask and/or establishment based on the existence of Zhongshan Dongfeng HuangShang Electronic Factory’s registration and possession of a registration number. In addition, display of the Medical Grade/Surgical Mask and Disease Prevention Mask for Child Certifications, each bearing the FDA logo, near images of and information about the respective products is misleading because such display implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the products and/or establishments based on the existence of the firms’ registrations and possession of registration numbers.

Passage 9

Although the KN95 Dust Mask and Medical Grade/Surgical Mask Certifications contain legible language that appears to be intended to function as a disclaimer, including a statement that the Certifications do not denote FDA endorsement or approval, statements that FDA does not issue or recognize certificates of registration, and a statement that quotes 21 CFR 807.39, the small font size and overall placement of such language could be easily overlooked and does not limit or otherwise mitigate the misleading impression created by the use of the Certifications.