21 U.S.C. § 360h — Notification and other remedies

Page 362 TITLE 21—FOOD AND DRUGS § 360h (b) Report Not later than September 30, 2023, and bienni- ally thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Rep- resentatives, and publish on the website of the Food and Drug Administration, a report on the number of postmarket device signals commu- nications issued by the Secretary, the sources of data for such signals, and how such signals were revised or resolved. (c) Rule of construction Nothing in this section shall be construed to require the delay of any regulatory decision- making or other action of the Food and Drug Administration. (Pub. L. 117–328, div. FF, title III, § 3307, Dec. 29, 2022, 136 Stat. 5834.) Editorial Notes CODIFICATION Section was enacted as part of the Food and Drug Omnibus Reform Act of 2022, and not as part of the Fed- eral Food, Drug, and Cosmetic Act which comprises this chapter. Statutory Notes and Related Subsidiaries DEFINITION OF ‘‘SECRETARY’’ Secretary as used in this section means the Secretary of Health and Human Services, see section 3002 of div. FF of Pub. L. 117–328, set out as a note under section 350a–1 of this title. § 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 distribu- tion presents an unreasonable risk of substan- tial harm to the public health, and (2) notification under this subsection is nec- essary 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 pre- scribe or use the device and to any other person (including manufacturers, importers, distribu- tors, retailers, and device users) who should properly receive such notification in order to eliminate such risk. An order under this sub- section 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 noti- fied 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 de- vice provide for the notification of the individ- uals 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 in- formal hearing, the Secretary determines that— (i) a device intended for human use which is introduced or delivered for introduction into interstate commerce for commercial distribu- tion presents an unreasonable risk of substan- tial 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, main- tenance, repair, or use of the device, and (iv) the notification authorized by sub- section (a) would not by itself be sufficient to eliminate the unreasonable risk and action de- scribed in paragraph (2) of this subsection is necessary to eliminate such risk, the Secretary may order the manufacturer, im- porter, 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 sen- tence which is directed to more than one person shall specify which person may decide which ac- tion shall be taken under such plan and the per- son specified shall be the person who the Sec- retary 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 profes- sional) other than the person he determines bears such responsibility. (B) The Secretary shall approve a plan sub- mitted pursuant to an order issued under sub- paragraph (A) unless he determines (after afford- ing 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 pre- scribed time, the Secretary shall (i) prescribe a plan to be carried out by the person or persons Page 363 TITLE 21—FOOD AND DRUGS § 360h to whom the order issued under subparagraph (A) was directed, or (ii) after affording an oppor- tunity for an informal hearing, by order pre- scribe a plan to be carried out by a person who is a manufacturer, importer, distributor, or re- tailer 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 de- vice (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 (ii) at the time the device user receives ac- tual notice of the unreasonable risk with re- spect 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, dis- tributor 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, im- porter, distributor, or retailer) who is entitled to such a remedy for any reasonable and foresee- able expenses actually incurred by such person in availing himself of such remedy. (c) Reimbursement An order issued under subsection (b) with re- spect to a device may require any person who is a manufacturer, importer, distributor, or re- tailer of the device to reimburse any other per- son who is a manufacturer, importer, dis- tributor, 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 re- quired 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 liabil- ity 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 rem- edy provided him under such order shall be taken into account. (e) Recall authority (1) If the Secretary finds that there is a rea- sonable 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 (in- cluding the manufacturers, importers, distribu- tors, or retailers of the device)— (A) to immediately cease distribution of such device, and (B) to immediately notify health profes- sionals and device user facilities of the order and to instruct such professionals and facili- ties to cease use of such device. The order shall provide the person subject to the order with an opportunity for an informal hear- ing, 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 de- vice. If, after providing an opportunity for such a hearing, the Secretary determines that inad- equate grounds exist to support the actions re- quired by the order, the Secretary shall vacate the order. (2)(A) If, after providing an opportunity for an informal hearing under paragraph (1), the Sec- retary determines that the order should be amended to include a recall of the device with respect to which the order was issued, the Sec- retary shall, except as provided in subpara- graphs (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 de- scribing the progress of the recall. (B) An amended order under subparagraph (A)— (i) shall— (I) not include recall of a device from indi- viduals, and (II) not include recall of a device from de- vice user facilities if the Secretary deter- mines 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 de- vice for individuals. If a significant number of such individuals cannot be identified, the Sec- retary 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 sub- sections (a), (b), and (c). (June 25, 1938, ch. 675, § 518, as added Pub. L. 94–295, § 2, May 28, 1976, 90 Stat. 562; amended Pub. L. 101–629, § 8, Nov. 28, 1990, 104 Stat. 4520; Pub. L. 102–300, § 4, June 16, 1992, 106 Stat. 239.) Editorial Notes 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). Page 364 TITLE 21—FOOD AND DRUGS § 360h–1 1 So in original. Probably should be followed by a semicolon. § 360h–1. Program to improve the device recall system (a) In general The Secretary shall— (1) establish a program to routinely and sys- tematically assess information relating to de- vice recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices; (2) clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner; (3) develop detailed criteria for assessing whether a person performing a device recall has performed an effective correction or ac- tion plan for the recall; and (4) document the basis for each termination by the Food and Drug Administration of a de- vice recall. (b) Assessment content The program established under subsection (a)(1) shall, at a minimum, identify— (1) trends in the number and types of device recalls; (2) devices that are most frequently the sub- ject of a recall; and (3) underlying causes of device recalls. (c) Definition In this section, the term ‘‘recall’’ means— (1) the removal from the market of a device pursuant to an order of the Secretary under subsection (b) or (e) of section 360h of this title; or (2) the correction or removal from the mar- ket of a device at the initiative of the manu- facturer or importer of the device that is re- quired to be reported to the Secretary under section 360i(g) of this title. (June 25, 1938, ch. 675, § 518A, as added Pub. L. 112–144, title VI, § 605, July 9, 2012, 126 Stat. 1053; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(K), Dec. 13, 2016, 130 Stat. 1154.) Editorial Notes AMENDMENTS 2016—Subsecs. (c), (d). Pub. L. 114–255 redesignated subsec. (d) as (c) and struck out former subsec. (c). Prior to amendment, text read as follows: ‘‘The Sec- retary shall document the basis for the termination by the Food and Drug Administration of a device recall.’’ § 360i. Records and reports on devices (a) General rule Every person who is a manufacturer or im- porter of a device intended for human use shall establish and maintain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such device is not adulterated or misbranded and to otherwise assure its safety and effectiveness. Regulations prescribed under the preceding sentence— (1) shall require a device manufacturer or importer to report to the Secretary whenever the manufacturer or importer receives or oth- erwise becomes aware of information that rea- sonably suggests that one of its marketed de- vices— (A) may have caused or contributed to a death or serious injury, or (B) has malfunctioned and that such de- vice or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious in- jury if the malfunction were to recur, which report under this subparagraph— (i) shall be submitted in accordance with part 803 of title 21, Code of Federal Regula- tions (or successor regulations), unless the Secretary grants an exemption or variance from, or an alternative to, a requirement under such regulations pursuant to section 803.19 of such part, if the device involved is— (I) a class III device; (II) a class II device that is perma- nently implantable, is life supporting, or is life sustaining; or (III) a type of device which the Sec- retary has, by notice published in the Federal Register or letter to the person who is the manufacturer or importer of the device, indicated should be subject to such part 803 in order to protect the pub- lic health; (ii) shall, if the device is not subject to clause (i), be submitted in accordance with criteria established by the Secretary for reports made pursuant to this clause, which criteria shall require the reports to be in summary form and made on a quar- terly basis; or (iii) shall, if the device is imported into the United States and for which part 803 of title 21, Code of Federal Regulations (or successor regulations) requires an im- porter to submit a report to the manufac- turer, be submitted by the importer to the manufacturer in accordance with part 803 of title 21, Code of Federal Regulations (or successor regulations) 1 (2) shall define the term ‘‘serious injury’’ to mean an injury that— (A) is life threatening, (B) results in permanent impairment of a body function or permanent damage to a body structure, or (C) necessitates medical or surgical inter- vention to preclude permanent impairment of a body function or permanent damage to a body structure; (3) shall require reporting of other signifi- cant adverse device experiences as determined by the Secretary to be necessary to be re- ported; (4) shall not impose requirements unduly burdensome to a device manufacturer or im- porter taking into account his cost of com- plying with such requirements and the need for the protection of the public health and the implementation of this chapter; (5) which prescribe the procedure for making requests for reports or information shall re-