--- kind: "section" citation: "21 C.F.R. § 864.1" title: "21" number: "864.1" heading: "Scope." url: "https://uscodex.org/cfr/21/864.1" --- # §864.1. Scope. - (a) This part sets forth the classification of hematology and pathology 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](/cfr/21/part807.md) may not 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 by [§ 807.87](/cfr/21/807.87.md). - (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. ## Notes ### Amendments [52 FR 17732, May 11, 1987, as amended at 69 FR 12273, Mar. 16, 2004; 78 FR 18233, Mar. 26, 2013; 79 FR 50552, Aug. 25, 2014] ### Authority Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371. ### Amendments [52 FR 17732, May 11, 1987, as amended at 69 FR 12273, Mar. 16, 2004; 78 FR 18233, Mar. 26, 2013; 79 FR 50552, Aug. 25, 2014]