UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

HHS - 21 CFR PART 882

NEUROLOGICAL DEVICES

active, Most Current
Organization: HHS
Publication Date: 1 April 2017
Status: active
Page Count: 24
scope:

(a) This part sets forth the classification of neurological 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 neurological 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
NEUROLOGICAL DEVICES
(a) This part sets forth the classification of neurological devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not...
April 1, 2019
NEUROLOGICAL DEVICES
(a) This part sets forth the classification of neurological devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not...
April 1, 2018
NEUROLOGICAL DEVICES
(a) This part sets forth the classification of neurological devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not...
21 CFR PART 882
April 1, 2017
NEUROLOGICAL DEVICES
(a) This part sets forth the classification of neurological devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not...
April 1, 2016
NEUROLOGICAL DEVICES
(a) This part sets forth the classification of neurological devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not...
April 1, 2015
NEUROLOGICAL DEVICES
(a) This part sets forth the classification of neurological devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not...
April 1, 2014
NEUROLOGICAL DEVICES
(a) This part sets forth the classification of neurological devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not...
Advertisement