
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360h]

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

(June 25, 1938, ch. 675, Sec. 518, as added Pub. L. 94-295, Sec. 2, May 
28, 1976, 90 Stat. 562; amended Pub. L. 101-629, Sec. 8, Nov. 28, 1990, 
104 Stat. 4520; Pub. L. 102-300, Sec. 4, June 16, 1992, 106 Stat. 239.)


                               Amendments

    1992--Subsec. (b)(1)(A)(ii). Pub. L. 102-300 substituted ``or'' for 
``and'' after ``properly designed'' and ``time of its design''.
    1990--Subsec. (e). Pub. L. 101-629 added subsec. (e).

                  Section Referred to in Other Sections

    This section is referred to in sections 331, 352, 360c, 360g, 360j 
of this title.
