§864.1. Scope.

This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution.

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 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.

References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

Guidance documents referenced in this part are available on the Internet at <I>http— //www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.