HHS - 21 CFR PART 866
IMMUNOLOGY AND MICROBIOLOGY DEVICES
|Publication Date:||1 April 2019|
(a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution.
(b) The indentification 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.
(c) To avoid duplicative listings, an immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device and as a microbiology device) is listed only in one subpart.
(d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
[52 FR 17733, May 11, 1987, as amended at 68 FR 5827, Feb. 5, 2003; 79 FR 50552, Aug. 25, 2014]