RE: Interesting9 Mar 2021 00:45
The WG 520 and WG 620 are offered for sale in the United States without marketing approval, clearance, or authorization from FDA. Accordingly, your 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 approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your products are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce these products into interstate commerce for commercial distribution as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
Interestingly the WSG website states that the main advantage of these products is that they are FDA registered- easy mistake to make???