§ 352(o), because your firm did not notify FDA of its intent to introduce the devices into commercial distribution in a notice or other information respecting modifications to these devices was not provided to FDA, as required by section 510(k) of the Act, 21 U.S.C. This device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g), 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. This inspection revealed that the i-STAT cTnI cartridges are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.
Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. These measurements are intended to be used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. Issuing Office: Center for Devices and Radiological Healthĭuring an inspection of your firm located in Ottawa, Canada on May 16, 2022, through May 19, 2022, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the i-STAT cTnI Test intended for the quantitative measurement of cardiac troponin I in whole blood or plasma.
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