PUBLIC LAW 94-295—MAY 28, 1976
90 STAT. 563
cial 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 and manufactured with reference to the state of the art as it existed at the time of its design and manufacture, " (iii) there are reasonable grounds to believe that the unreasonable risk was not caused by failure of a person other than a maniif acturer, 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) 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 Hearing, 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 Hearing, 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 e<juivalent device which is in conformity with all applicable requirements of this Act. "(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), or
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