Shenzhen Weifa Technology Co., Ltd

Selected passages from the FDA letter

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

Passage 1

The FFP1 3-ply Non-Woven EarLoop Mask and the N95/FFP2 Respirator***1*** are being offered for sale in the United States without marketing approval, clearance, or authorization from FDA. Accordingly, 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

In addition, the FFP1 3-ply Non-Woven EarLoop Mask and N95/FFP2 Respirator are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because their labeling is false or misleading. The devices are not “FDA certificated” and so express statements to the contrary are false. Moreover, 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 your 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 N95/FFP2 Respirator are misleading and constitute misbranding. *See* 21 CFR 807.39.

Passage 4

Stating that the devices are “FDA certificated” and that the devices are “official certificated…FDA.”

Passage 5

Unauthorized display of FDA’s logo***2*** alongside the devices’ product information.

Passage 6

Displaying a “Certification of FDA Registration” (Certification) issued by “Shenzhen CCT Testing Technology Co. Ltd.” alongside N95/FFP2 Respirator product information. The Certification “certifies that Shenzhen Weifa Technology Co., Ltd … 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 7

In addition, taken together, display of the FDA logo and Certification positioned near images of and information about the N95/FFP2 Respirator are misleading because they imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the N95/FFP2 Respirator and/or establishment based on the existence of your firm’s registration and possession of a registration number. Although the Certification contains language that appears to be intended to function as a disclaimer, including a statement that the Certification does 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 the language could be easily overlooked and do not limit or otherwise mitigate the misleading impression created by the use of the Certification.