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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.

Passage 4

the HealReg Service Certificate, bearing the FDA logo, positioned near images of and information about the KN95 Dust Mask are misleading because they imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and/or establishment based on the representations that Zhongshan Dongfeng HuangShang Electronic Factory is or was registered with FDA and that the firm is or was in possession of a registration number.