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HHS - 21 CFR PART 861

PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT

active, Most Current
Organization: HHS
Publication Date: 1 April 2014
Status: active
Page Count: 5
scope:

Purpose and scope.

(a) This part implements section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment, amendment, and revocation of performance standards applicable to devices intended for human use.

(b) The Food and Drug Administration may determine that a performance standard, as described under special controls for class II devices in ยง 860.7(b) of this chapter, is necessary to provide reasonable assurance of the safety and effectiveness of the device. Performance standards may be established for:

(1) A class II device;

(2) A class III device which, upon the effective date of the standard, is reclassified into class II; and

(3) A class III device, as a condition to premarket approval under section 515 of the act, to reduce or eliminate a risk or risks associated with such device.

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

Document History

April 1, 2020
PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
Purpose and scope. (a) This part implements section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment, amendment, and revocation of performance standards...
April 1, 2019
PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
Purpose and scope. (a) This part implements section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment, amendment, and revocation of performance standards...
April 1, 2018
PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
Purpose and scope. (a) This part implements section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment, amendment, and revocation of performance standards...
April 1, 2017
PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
Purpose and scope. (a) This part implements section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment, amendment, and revocation of performance standards...
April 1, 2016
PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
Purpose and scope. (a) This part implements section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment, amendment, and revocation of performance standards...
April 1, 2015
PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
Purpose and scope. (a) This part implements section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment, amendment, and revocation of performance standards...
21 CFR PART 861
April 1, 2014
PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
Purpose and scope. (a) This part implements section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment, amendment, and revocation of performance standards...
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