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HHS - 21 CFR PART 862

CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

active, Most Current
Organization: HHS
Publication Date: 1 April 2017
Status: active
Page Count: 42
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 ยง 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.

Document History

April 1, 2019
CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
(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...
April 1, 2018
CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
(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...
21 CFR PART 862
April 1, 2017
CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
(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...
April 1, 2016
CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
(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...
April 1, 2015
CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
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...
April 1, 2014
CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
(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...

References

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