21 U.S.C. § 360f : US Code - Section 360F: Banned devices

Search 21 U.S.C. § 360f : US Code - Section 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.