part_subject: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
subpart_code: "A"
subpart_subject: "General Provisions"
section_number: "862.1"
section_subject: "Scope."
cfr_reference: "21 CFR 862.1"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)This part sets forth the classification of clinical chemistry and clinical toxicology devices intended for human use that are in commercial distribution.
(b)The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required in § 807.87.
(c)References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
(d)Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.