21 CFR 862.1 - Scope.
(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.
- 21 CFR 862.1055 — Newborn Screening Test System for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry.
- 21 CFR 862.3360 — Drug Metabolizing Enzyme Genotyping System.
- 21 CFR 862.1163 — Cardiac Allograft Gene Expression Profiling Test System.
- 21 CFR 862.3840 — Sirolimus Test System.
- 21 CFR 862.1235 — Cyclosporine Test System.
- 21 CFR 862.3080 — Breath Nitric Oxide Test System.
- 21 CFR 862.1678 — Tacrolimus Test System.
- 21 CFR 862.2570 — Instrumentation for Clinical Multiplex Test Systems.