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HHS - 21 CFR PART 880

GENERAL HOSPITAL AND PERSONAL USE DEVICES

active, Most Current
Organization: HHS
Publication Date: 1 April 2018
Status: active
Page Count: 27
scope:

(a) This part sets forth the classification of general hospital and personal use 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 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, a general hospital and personal use device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic 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.

(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
GENERAL HOSPITAL AND PERSONAL USE DEVICES
(a) This part sets forth the classification of general hospital and personal use devices intended for human use that are in commercial distribution. (b) The identification of a device in a...
April 1, 2019
GENERAL HOSPITAL AND PERSONAL USE DEVICES
(a) This part sets forth the classification of general hospital and personal use devices intended for human use that are in commercial distribution. (b) The identification of a device in a...
21 CFR PART 880
April 1, 2018
GENERAL HOSPITAL AND PERSONAL USE DEVICES
(a) This part sets forth the classification of general hospital and personal use devices intended for human use that are in commercial distribution. (b) The identification of a device in a...
April 1, 2017
GENERAL HOSPITAL AND PERSONAL USE DEVICES
(a) This part sets forth the classification of general hospital and personal use devices intended for human use that are in commercial distribution. (b) The identification of a device in a...
April 1, 2016
GENERAL HOSPITAL AND PERSONAL USE DEVICES
(a) This part sets forth the classification of general hospital and personal use devices intended for human use that are in commercial distribution. (b) The identification of a device in a...
April 1, 2015
GENERAL HOSPITAL AND PERSONAL USE DEVICES
(a) This part sets forth the classification of general hospital and personal use devices intended for human use that are in commercial distribution. (b) The identification of a device in a...
April 1, 2014
GENERAL HOSPITAL AND PERSONAL USE DEVICES
(a) This part sets forth the classification of general hospital and personal use devices intended for human use that are in commercial distribution. (b) The identification of a device in a...

References

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