21 CFR 895.20 - General.

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§ 895.20 General.

The Commissioner may initiate a proceeding to make a device a banned device whenever the Commissioner finds, on the basis of all available data and information, that the device presents substantial deception or an unreasonable and substantial risk of illness or injury that the Commissioner determines cannot be, or has not been, corrected or eliminated by labeling or by a change in labeling, or by a change in advertising if the device is a restricted device.

[44 FR 29221, May 18, 1979, as amended at 57 FR 58405, Dec. 10, 1992]

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.

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United States Code

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 895 after this date.

  • 2015-06-02; vol. 80 # 105 - Tuesday, June 2, 2015
    1. 80 FR 31299 - Banned Devices; General Provisions; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective June 2, 2015.
      21 CFR Part 895