21 CFR Part 882 - NEUROLOGICAL DEVICES | US Law | LII / Legal Information Institute

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Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

Source:

44 FR 51730, Sept. 4, 1979, unless otherwise noted.

Editorial Note:

Nomenclature changes to part 882 appear at 73 FR 35341, June 23, 2008.

Title 21 published on 2015-04-01.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

2015-08-17; vol. 80 # 158 - Monday, August 17, 2015

80 FR 49136 - Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid

GPO FDSys: XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2015-20177
RIN
Docket No.	FDA-2015-N-2737

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final order.

This order is effective September 16, 2015. The classification was applicable on June 5, 2015.

21 CFR Part 882

Summary

The Food and Drug Administration (FDA) is classifying the computerized cognitive assessment aid into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the computerized cognitive assessment aid's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

U.S. Code: Title 21 - FOOD AND DRUGS

§ 351 - Adulterated drugs and devices

§ 360 - Registration of producers of drugs or devices

§ 360c - Classification of devices intended for human use

§ 360e - Premarket approval

§ 360j - General provisions respecting control of devices intended for human use

§ 371 - Regulations and hearings

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 882 after this date.