21 U.S.C. § 360h : US Code - Section 360H: Notification and other remedies

Search 21 U.S.C. § 360h : US Code - Section 360H: Notification and other remedies

(a) Notification
If the Secretary determines that -
(1) a device intended for human use which is introduced or
delivered for introduction into interstate commerce for
commercial distribution presents an unreasonable risk of
substantial harm to the public health, and
(2) notification under this subsection is necessary to
eliminate the unreasonable risk of such harm and no more
practicable means is available under the provisions of this
chapter (other than this section) to eliminate such risk,
the Secretary may issue such order as may be necessary to assure
that adequate notification is provided in an appropriate form, by
the persons and means best suited under the circumstances involved,
to all health professionals who prescribe or use the device and to
any other person (including manufacturers, importers, distributors,
retailers, and device users) who should properly receive such
notification in order to eliminate such risk. An order under this
subsection shall require that the individuals subject to the risk
with respect to which the order is to be issued be included in the
persons to be notified of the risk unless the Secretary determines
that notice to such individuals would present a greater danger to
the health of such individuals than no such notification. If the
Secretary makes such a determination with respect to such
individuals, the order shall require that the health professionals
who prescribe or use the device provide for the notification of the
individuals whom the health professionals treated with the device
of the risk presented by the device and of any action which may be
taken by or on behalf of such individuals to eliminate or reduce
such risk. Before issuing an order under this subsection, the
Secretary shall consult with the persons who are to give notice
under the order.
(b) Repair, replacement, or refund
(1)(A) If, after affording opportunity for an informal hearing,
the Secretary determines that -
(i) a device intended for human use which is introduced or
delivered for introduction into interstate commerce for
commercial distribution presents an unreasonable risk of
substantial harm to the public health,
(ii) there are reasonable grounds to believe that the device
was not properly designed or manufactured with reference to the
state of the art as it existed at the time of its design or
manufacture,
(iii) there are reasonable grounds to believe that the
unreasonable risk was not caused by failure of a person other
than a manufacturer, importer, distributor, or retailer of the
device to exercise due care in the installation, maintenance,
repair, or use of the device, and
(iv) the notification authorized by subsection (a) of this
section would not by itself be sufficient to eliminate the
unreasonable risk and action described in paragraph (2) of this
subsection is necessary to eliminate such risk,
the Secretary may order the manufacturer, importer, or any
distributor of such device, or any combination of such persons, to
submit to him within a reasonable time a plan for taking one or
more of the actions described in paragraph (2). An order issued
under the preceding sentence which is directed to more than one
person shall specify which person may decide which action shall be
taken under such plan and the person specified shall be the person
who the Secretary determines bears the principal, ultimate
financial responsibility for action taken under the plan unless the
Secretary cannot determine who bears such responsibility or the
Secretary determines that the protection of the public health
requires that such decision be made by a person (including a device
user or health professional) other than the person he determines
bears such responsibility.
(B) The Secretary shall approve a plan submitted pursuant to an
order issued under subparagraph (A) unless he determines (after
affording opportunity for an informal hearing) that the action or
actions to be taken under the plan or the manner in which such
action or actions are to be taken under the plan will not assure
that the unreasonable risk with respect to which such order was
issued will be eliminated. If the Secretary disapproves a plan, he
shall order a revised plan to be submitted to him within a
reasonable time. If the Secretary determines (after affording
opportunity for an informal hearing) that the revised plan is
unsatisfactory or if no revised plan or no initial plan has been
submitted to the Secretary within the prescribed time, the
Secretary shall (i) prescribe a plan to be carried out by the
person or persons to whom the order issued under subparagraph (A)
was directed, or (ii) after affording an opportunity for an
informal hearing, by order prescribe a plan to be carried out by a
person who is a manufacturer, importer, distributor, or retailer of
the device with respect to which the order was issued but to whom
the order under subparagraph (A) was not directed.
(2) The actions which may be taken under a plan submitted under
an order issued under paragraph (1) are as follows:
(A) To repair the device so that it does not present the
unreasonable risk of substantial harm with respect to which the
order under paragraph (1) was issued.
(B) To replace the device with a like or equivalent device
which is in conformity with all applicable requirements of this
chapter.
(C) To refund the purchase price of the device (less a
reasonable allowance for use if such device has been in the
possession of the device user for one year or more -
(i) at the time of notification ordered under subsection (a)
of this section, or
(ii) at the time the device user receives actual notice of
the unreasonable risk with respect to which the order was
issued under paragraph (1),
whichever first occurs).
(3) No charge shall be made to any person (other than a
manufacturer, importer, distributor or retailer) for availing
himself of any remedy, described in paragraph (2) and provided
under an order issued under paragraph (1), and the person subject
to the order shall reimburse each person (other than a
manufacturer, importer, distributor, or retailer) who is entitled
to such a remedy for any reasonable and foreseeable expenses
actually incurred by such person in availing himself of such
remedy.
(c) Reimbursement
An order issued under subsection (b) of this section with respect
to a device may require any person who is a manufacturer, importer,
distributor, or retailer of the device to reimburse any other
person who is a manufacturer, importer, distributor, or retailer of
such device for such other person's expenses actually incurred in
connection with carrying out the order if the Secretary determines
such reimbursement is required for the protection of the public
health. Any such requirement shall not affect any rights or
obligations under any contract to which the person receiving
reimbursement or the person making such reimbursement is a party.
(d) Effect on other liability
Compliance with an order issued under this section shall not
relieve any person from liability under Federal or State law. In
awarding damages for economic loss in an action brought for the
enforcement of any such liability, the value to the plaintiff in
such action of any remedy provided him under such order shall be
taken into account.
(e) Recall authority
(1) If the Secretary finds that there is a reasonable probability
that a device intended for human use would cause serious, adverse
health consequences or death, the Secretary shall issue an order
requiring the appropriate person (including the manufacturers,
importers, distributors, or retailers of the device) -
(A) to immediately cease distribution of such device, and
(B) to immediately notify health professionals and device user
facilities of the order and to instruct such professionals and
facilities to cease use of such device.
The order shall provide the person subject to the order with an
opportunity for an informal hearing, to be held not later than 10
days after the date of the issuance of the order, on the actions
required by the order and on whether the order should be amended to
require a recall of such device. If, after providing an opportunity
for such a hearing, the Secretary determines that inadequate
grounds exist to support the actions required by the order, the
Secretary shall vacate the order.
(2)(A) If, after providing an opportunity for an informal hearing
under paragraph (1), the Secretary determines that the order should
be amended to include a recall of the device with respect to which
the order was issued, the Secretary shall, except as provided in
subparagraphs (B) and (C), amend the order to require a recall. The
Secretary shall specify a timetable in which the device recall will
occur and shall require periodic reports to the Secretary
describing the progress of the recall.
(B) An amended order under subparagraph (A) -
(i) shall -
(I) not include recall of a device from individuals, and
(II) not include recall of a device from device user
facilities if the Secretary determines that the risk of
recalling such device from the facilities presents a greater
health risk than the health risk of not recalling the device
from use, and
(ii) shall provide for notice to individuals subject to the
risks associated with the use of such device.
In providing the notice required by clause (ii), the Secretary may
use the assistance of health professionals who prescribed or used
such a device for individuals. If a significant number of such
individuals cannot be identified, the Secretary shall notify such
individuals pursuant to section 375(b) of this title.
(3) The remedy provided by this subsection shall be in addition
to remedies provided by subsections (a), (b), and (c) of this
section.