
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360f]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 360f. Banned devices


(a) General rule

    Whenever the Secretary finds, on the basis of all available data and 
information, that--
        (1) a device intended for human use presents substantial 
    deception or an unreasonable and substantial risk of illness or 
    injury; and
        (2) in the case of substantial deception or an unreasonable and 
    substantial risk of illness or injury which the Secretary determined 
    could be corrected or eliminated by labeling or change in labeling 
    and with respect to which the Secretary provided written notice to 
    the manufacturer specifying the deception or risk of illness or 
    injury, the labeling or change in labeling to correct the deception 
    or eliminate or reduce such risk, and the period within which such 
    labeling or change in labeling was to be done, such labeling or 
    change in labeling was not done within such period;

he may initiate a proceeding to promulgate a regulation to make such 
device a banned device.

(b) Special effective date

    The Secretary may declare a proposed regulation under subsection (a) 
of this section to be effective upon its publication in the Federal 
Register and until the effective date of any final action taken 
respecting such regulation if (1) he determines, on the basis of all 
available data and information, that the deception or risk of illness or 
injury associated with the use of the device which is subject to the 
regulation presents an unreasonable, direct, and substantial danger to 
the health of individuals, and (2) before the date of the publication of 
such regulation, the Secretary notifies the manufacturer of such device 
that such regulation is to be made so effective. If the Secretary makes 
a proposed regulation so effective, he shall, as expeditiously as 
possible, give interested persons prompt notice of his action under this 
subsection, provide reasonable opportunity for an informal hearing on 
the proposed regulation, and either affirm, modify, or revoke such 
proposed regulation.

(June 25, 1938, ch. 675, Sec. 516, as added Pub. L. 94-295, Sec. 2, May 
28, 1976, 90 Stat. 560; amended Pub. L. 101-629, Sec. 18(d), Nov. 28, 
1990, 104 Stat. 4529.)


                               Amendments

    1990--Subsec. (a). Pub. L. 101-629 struck out ``and after 
consultation with the appropriate panel or panels under section 360c of 
this title'' after ``data and information'' in introductory provisions 
and struck out at end ``The Secretary shall afford all interested 
persons opportunity for an informal hearing on a regulation proposed 
under this subsection.''

                  Section Referred to in Other Sections

    This section is referred to in sections 331, 360c, 360e, 360g, 360j, 
381, 382 of this title.
