---
kind: "section"
citation: "21 U.S.C. § 360h"
title: "21"
title_heading: "Food and Drugs"
number: "360h"
heading: "Notification and other remedies"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360h"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §360h. Notification and other remedies

- (a) **Notification—** If the [Secretary](/usc/21/321.md?p=d) determines that—
  - (1) a [device](/usc/21/321.md?p=h-1) intended for human use which is introduced or delivered for introduction into [interstate commerce](/usc/21/321.md?p=b) for commercial [distribution](/usc/21/360eee.md?p=5) 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](/usc/21/321.md?p=d) may issue such order as may be necessary to assure that adequate notification is provided in an appropriate form, by the [persons](/usc/21/321.md?p=e) and means best suited under the circumstances involved, to all health professionals who prescribe or use the [device](/usc/21/321.md?p=h-1) and to any other [person](/usc/21/321.md?p=e) (including [manufacturers](/usc/21/360hh.md?p=3), importers, distributors, retailers, and [device](/usc/21/321.md?p=h-1) 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](/usc/21/321.md?p=e) to be notified of the risk unless the [Secretary](/usc/21/321.md?p=d) determines that notice to such individuals would present a greater danger to the health of such individuals than no such notification. If the [Secretary](/usc/21/321.md?p=d) makes such a determination with respect to such individuals, the order shall require that the health professionals who prescribe or use the [device](/usc/21/321.md?p=h-1) provide for the notification of the individuals whom the health professionals treated with the [device](/usc/21/321.md?p=h-1) of the risk presented by the [device](/usc/21/321.md?p=h-1) 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](/usc/21/321.md?p=d) shall consult with the [persons](/usc/21/321.md?p=e) who are to give notice under the order.

- (b) **Repair, replacement, or refund—**
  - (1)
    - (A) If, after affording opportunity for an [informal hearing](/usc/21/321.md?p=x), the [Secretary](/usc/21/321.md?p=d) determines that—
      - (i) a [device](/usc/21/321.md?p=h-1) intended for human use which is introduced or delivered for introduction into [interstate commerce](/usc/21/321.md?p=b) for commercial [distribution](/usc/21/360eee.md?p=5) presents an unreasonable risk of substantial harm to the public health,
      - (ii) there are reasonable grounds to believe that the [device](/usc/21/321.md?p=h-1) was not properly designed or manufactured with reference to the [state](/usc/21/321.md?p=a-1) 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](/usc/21/321.md?p=e) other than a [manufacturer](/usc/21/360hh.md?p=3), importer, distributor, or retailer of the [device](/usc/21/321.md?p=h-1) to exercise due care in the installation, maintenance, repair, or use of the [device](/usc/21/321.md?p=h-1), and
      - (iv) the notification [authorized](/usc/21/360eee.md?p=2) by [subsection (a)](#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](/usc/21/321.md?p=d) may order the [manufacturer](/usc/21/360hh.md?p=3), importer, or any distributor of such [device](/usc/21/321.md?p=h-1), or any combination of such [persons](/usc/21/321.md?p=e), to submit to him within a reasonable time a plan for taking one or more of the actions described in [paragraph (2)](#b-2). An order issued under the preceding sentence which is directed to more than one [person](/usc/21/321.md?p=e) shall specify which [person](/usc/21/321.md?p=e) may decide which action shall be taken under such plan and the [person](/usc/21/321.md?p=e) specified shall be the [person](/usc/21/321.md?p=e) who the [Secretary](/usc/21/321.md?p=d) determines bears the principal, ultimate financial responsibility for action taken under the plan unless the [Secretary](/usc/21/321.md?p=d) cannot determine who bears such responsibility or the [Secretary](/usc/21/321.md?p=d) determines that the protection of the public health requires that such decision be made by a [person](/usc/21/321.md?p=e) (including a [device](/usc/21/321.md?p=h-1) user or health professional) other than the [person](/usc/21/321.md?p=e) he determines bears such responsibility.

    - (B) The [Secretary](/usc/21/321.md?p=d) shall approve a plan submitted pursuant to an order issued under [subparagraph (A)](#b-1-A) unless he determines (after affording opportunity for an [informal hearing](/usc/21/321.md?p=x)) 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](/usc/21/321.md?p=d) disapproves a plan, he shall order a revised plan to be submitted to him within a reasonable time. If the [Secretary](/usc/21/321.md?p=d) determines (after affording opportunity for an [informal hearing](/usc/21/321.md?p=x)) that the revised plan is unsatisfactory or if no revised plan or no initial plan has been submitted to the [Secretary](/usc/21/321.md?p=d) within the prescribed time, the [Secretary](/usc/21/321.md?p=d) shall (i) prescribe a plan to be carried out by the [person](/usc/21/321.md?p=e) or [persons](/usc/21/321.md?p=e) to whom the order issued under [subparagraph (A)](#b-1-A) was directed, or (ii) after affording an opportunity for an [informal hearing](/usc/21/321.md?p=x), by order prescribe a plan to be carried out by a [person](/usc/21/321.md?p=e) who is a [manufacturer](/usc/21/360hh.md?p=3), importer, distributor, or retailer of the [device](/usc/21/321.md?p=h-1) with respect to which the order was issued but to whom the order under [subparagraph (A)](#b-1-A) was not directed.
  - (2) The actions which may be taken under a plan submitted under an order issued under [paragraph (1)](#b-1) are as follows:
    - (A) To repair the [device](/usc/21/321.md?p=h-1) so that it does not present the unreasonable risk of substantial harm with respect to which the order under [paragraph (1)](#b-1) was issued.
    - (B) To replace the [device](/usc/21/321.md?p=h-1) with a like or equivalent [device](/usc/21/321.md?p=h-1) which is in conformity with all applicable requirements of this chapter.
    - (C) To refund the purchase price of the [device](/usc/21/321.md?p=h-1) (less a reasonable allowance for use if such [device](/usc/21/321.md?p=h-1) has been in the possession of the [device](/usc/21/321.md?p=h-1) user for one year or more—
      - (i) at the time of notification ordered under [subsection (a)](#a), or
      - (ii) at the time the [device](/usc/21/321.md?p=h-1) user receives actual notice of the unreasonable risk with respect to which the order was issued under [paragraph (1)](#b-1),

      whichever first occurs).

  - (3) No charge shall be made to any [person](/usc/21/321.md?p=e) (other than a [manufacturer](/usc/21/360hh.md?p=3), importer, distributor or retailer) for availing himself of any remedy, described in [paragraph (2)](#b-2) and provided under an order issued under [paragraph (1)](#b-1), and the [person](/usc/21/321.md?p=e) subject to the order shall reimburse each [person](/usc/21/321.md?p=e) (other than a [manufacturer](/usc/21/360hh.md?p=3), importer, distributor, or retailer) who is entitled to such a remedy for any reasonable and foreseeable expenses actually incurred by such [person](/usc/21/321.md?p=e) in availing himself of such remedy.
- (c) **Reimbursement—** An order issued under [subsection (b)](#b) with respect to a [device](/usc/21/321.md?p=h-1) may require any [person](/usc/21/321.md?p=e) who is a [manufacturer](/usc/21/360hh.md?p=3), importer, distributor, or retailer of the [device](/usc/21/321.md?p=h-1) to reimburse any other [person](/usc/21/321.md?p=e) who is a [manufacturer](/usc/21/360hh.md?p=3), importer, distributor, or retailer of such [device](/usc/21/321.md?p=h-1) for such other [person](/usc/21/321.md?p=e)’s expenses actually incurred in connection with carrying out the order if the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=e) receiving reimbursement or the [person](/usc/21/321.md?p=e) making such reimbursement is a party.
- (d) **Effect on other liability—** Compliance with an order issued under this section shall not relieve any [person](/usc/21/321.md?p=e) from liability under Federal or [State](/usc/21/321.md?p=a-1) 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](/usc/21/321.md?p=d) finds that there is a reasonable probability that a [device](/usc/21/321.md?p=h-1) intended for human use would cause serious, adverse health consequences or death, the [Secretary](/usc/21/321.md?p=d) shall issue an order requiring the appropriate [person](/usc/21/321.md?p=e) (including the [manufacturers](/usc/21/360hh.md?p=3), importers, distributors, or retailers of the [device](/usc/21/321.md?p=h-1))—
    - (A) to immediately cease [distribution](/usc/21/360eee.md?p=5) of such [device](/usc/21/321.md?p=h-1), and
    - (B) to immediately notify health professionals and [device](/usc/21/321.md?p=h-1) user facilities of the order and to instruct such professionals and facilities to cease use of such [device](/usc/21/321.md?p=h-1).

    The order shall provide the [person](/usc/21/321.md?p=e) subject to the order with an opportunity for an [informal hearing](/usc/21/321.md?p=x), 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](/usc/21/321.md?p=h-1). If, after providing an opportunity for such a hearing, the [Secretary](/usc/21/321.md?p=d) determines that inadequate grounds exist to support the actions required by the order, the [Secretary](/usc/21/321.md?p=d) shall vacate the order.

  - (2)
    - (A) If, after providing an opportunity for an [informal hearing](/usc/21/321.md?p=x) under [paragraph (1)](#e-1), the [Secretary](/usc/21/321.md?p=d) determines that the order should be amended to include a recall of the [device](/usc/21/321.md?p=h-1) with respect to which the order was issued, the [Secretary](/usc/21/321.md?p=d) shall, except as provided in subparagraphs [(B)](#e-2-B) and (C), amend the order to require a recall. The [Secretary](/usc/21/321.md?p=d) shall specify a timetable in which the [device](/usc/21/321.md?p=h-1) recall will occur and shall require periodic reports to the [Secretary](/usc/21/321.md?p=d) describing the progress of the recall.
    - (B) An amended order under [subparagraph (A)](#e-2-A)—
      - (i) shall—
        - (I) not include recall of a [device](/usc/21/321.md?p=h-1) from individuals, and
        - (II) not include recall of a [device](/usc/21/321.md?p=h-1) from [device](/usc/21/321.md?p=h-1) user facilities if the [Secretary](/usc/21/321.md?p=d) determines that the risk of recalling such [device](/usc/21/321.md?p=h-1) from the facilities presents a greater health risk than the health risk of not recalling the [device](/usc/21/321.md?p=h-1) from use, and
      - (ii) shall provide for notice to individuals subject to the risks associated with the use of such [device](/usc/21/321.md?p=h-1).

      In providing the notice required by [clause (ii)](#e-2-B-ii), the [Secretary](/usc/21/321.md?p=d) may use the assistance of health professionals who prescribed or used such a [device](/usc/21/321.md?p=h-1) for individuals. If a significant number of such individuals cannot be identified, the [Secretary](/usc/21/321.md?p=d) shall notify such individuals pursuant to [section 375(b) of this title](/usc/21/375.md?p=b).

  - (3) The remedy provided by this subsection shall be in addition to remedies provided by subsections [(a)](#a), [(b)](#b), and [(c)](#c).

## Source credit

(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.)

## Notes

### 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).