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HHS - 21 CFR PART 892

RADIOLOGY DEVICES

active, Most Current
Organization: HHS
Publication Date: 1 April 2014
Status: active
Page Count: 15
scope:

(a) This part sets forth the classification of radiology 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 provision of a regulation in this part but shall state why the device is substantially equivalent to other devices, as required by ยง 807.87.

(c) To avoid duplicative listings, a radiology device that has two or more types of uses (e.g., use both as a diagnostic device and a therapeutic device) is listed in one subpart only.

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

(e) 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, 2020
RADIOLOGY DEVICES
(a) This part sets forth the classification of radiology 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...
April 1, 2019
RADIOLOGY DEVICES
(a) This part sets forth the classification of radiology 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...
April 1, 2018
RADIOLOGY DEVICES
(a) This part sets forth the classification of radiology 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...
April 1, 2017
RADIOLOGY DEVICES
This part sets forth the classification of radiology 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...
April 1, 2016
RADIOLOGY DEVICES
(a) This part sets forth the classification of radiology 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...
April 1, 2015
RADIOLOGY DEVICES
(a) This part sets forth the classification of radiology 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...
21 CFR PART 892
April 1, 2014
RADIOLOGY DEVICES
(a) This part sets forth the classification of radiology 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...
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