Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1FDA has determined that your sample self-collection kits are adulterated under section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. 351(f)(1)(B) because they do not have an approved premarket approval application (PMA) in effect pursuant to section 515(a) of the FD&C Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the FD&C Act, 21 U.S.C. 360j(g).
Passage 2Your sample self-collection kits are also misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o), because notification of the intent to introduce the device into commercial distribution has not been provided to the Agency, as required by section 510(k) of the FD&C Act, 21 U.S.C. 360(k).