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

# §360l. Postmarket surveillance

- (a) **Postmarket surveillance—**
  - (1) **In general—**
    - (A) **Conduct—** The [Secretary](/usc/21/321.md?p=d) may by order, at the time of approval or clearance of a [device](/usc/21/321.md?p=h-1) or at any time thereafter, require a [manufacturer](/usc/21/360hh.md?p=3) to conduct postmarket surveillance for any [device](/usc/21/321.md?p=h-1) of the [manufacturer](/usc/21/360hh.md?p=3) that is a class II or class III [device](/usc/21/321.md?p=h-1)—
      - (i) the failure of which would be reasonably likely to have serious adverse health consequences;
      - (ii) that is expected to have significant use in pediatric populations; or
      - (iii) that is intended to be—
        - (I) implanted in the human body for more than 1 year; or
        - (II) a life-sustaining or life-supporting [device](/usc/21/321.md?p=h-1) used outside a [device](/usc/21/321.md?p=h-1) user facility.
    - (B) **Condition—** The [Secretary](/usc/21/321.md?p=d) may order a postmarket surveillance under [subparagraph (A)](#a-1-A) as a condition to approval or clearance of a [device](/usc/21/321.md?p=h-1) described in [subparagraph (A)(ii)](#a-1-A-ii).
  - (2) **Rule of construction—** The provisions of [paragraph (1)](#a-1) shall have no effect on authorities otherwise provided under the[^1] chapter or regulations issued under this chapter.
- (b) **Surveillance approval—**
  - (1) **In general—** Each [manufacturer](/usc/21/360hh.md?p=3) required to conduct a surveillance of a [device](/usc/21/321.md?p=h-1) shall, within 30 days of receiving an order from the [Secretary](/usc/21/321.md?p=d) prescribing that the [manufacturer](/usc/21/360hh.md?p=3) is required under this section to conduct such surveillance, submit, for the approval of the [Secretary](/usc/21/321.md?p=d), a plan for the required surveillance. The [Secretary](/usc/21/321.md?p=d), within 60 days of the receipt of such plan, shall determine if the [person](/usc/21/321.md?p=e) designated to conduct the surveillance has appropriate qualifications and experience to undertake such surveillance and if the plan will result in the collection of useful data that can reveal unforeseen adverse events or other information necessary to protect the public health. The [manufacturer](/usc/21/360hh.md?p=3) shall commence surveillance under this section not later than 15 months after the day on which the [Secretary](/usc/21/321.md?p=d) issues an order under this section. Except as provided in [paragraph (2)](#b-2), the [Secretary](/usc/21/321.md?p=d), in consultation with the [manufacturer](/usc/21/360hh.md?p=3), may by order require a prospective surveillance period of up to 36 months. Except as provided in [paragraph (2)](#b-2), any determination by the [Secretary](/usc/21/321.md?p=d) that a longer period is necessary shall be made by mutual agreement between the [Secretary](/usc/21/321.md?p=d) and the [manufacturer](/usc/21/360hh.md?p=3) or, if no agreement can be reached, after the completion of a dispute resolution process as described in [section 360bbb–1 of this title](/usc/21/360bbb–1.md).
  - (2) **Longer surveillance for pediatric devices—** The [Secretary](/usc/21/321.md?p=d) may by order require a prospective surveillance period of more than 36 months with respect to a [device](/usc/21/321.md?p=h-1) that is expected to have significant use in pediatric populations if such period of more than 36 months is necessary in order to assess the impact of the [device](/usc/21/321.md?p=h-1) on growth and development, or the effects of growth, development, activity level, or other factors on the safety or efficacy of the [device](/usc/21/321.md?p=h-1).
- (c) **Dispute resolution—** A [manufacturer](/usc/21/360hh.md?p=3) may request review under [section 360bbb–1 of this title](/usc/21/360bbb–1.md) of any order or condition requiring postmarket surveillance under this section. During the pendency of such review, the [device](/usc/21/321.md?p=h-1) subject to such a postmarket surveillance order or condition shall not, because of noncompliance with such order or condition, be deemed in violation of [section 331(q)(1)(C) of this title](/usc/21/331.md?p=q-1-C), adulterated under [section 351(f)(1) of this title](/usc/21/351.md?p=f-1), misbranded under [section 352(t)(3) of this title](/usc/21/352.md), or in violation of, as applicable, [section 360(k) of this title](/usc/21/360.md?p=k) or [section 360e of this title](/usc/21/360e.md), unless deemed necessary to protect the public health.

## Footnotes

[^1]: So in original. Probably should be “this”.

## Source credit

(June 25, 1938, ch. 675, § 522, as added Pub. L. 101–629, § 10, Nov. 28, 1990, 104 Stat. 4521; amended Pub. L. 102–300, § 3(b), June 16, 1992, 106 Stat. 239; Pub. L. 105–115, title II, § 212, Nov. 21, 1997, 111 Stat. 2346; Pub. L. 110–85, title III, § 307, Sept. 27, 2007, 121 Stat. 865; Pub. L. 112–144, title VI, § 616, July 9, 2012, 126 Stat. 1062.)

## Notes

### Editorial Notes

### Amendments

2012—Subsec. (a)(1)(A). Pub. L. 112–144, § 616(1), inserted “, at the time of approval or clearance of a device or at any time thereafter,” after “by order” in introductory provisions.

Subsec. (b)(1). Pub. L. 112–144, § 616(2), inserted “The manufacturer shall commence surveillance under this section not later than 15 months after the day on which the Secretary issues an order under this section.” after “the public health.”

2007—Pub. L. 110–85, § 307(1), made technical amendment to section catchline.

Subsec. (a). Pub. L. 110–85, § 307(2), added subsec. (a) and struck out former subsec. (a). Prior to amendment, text read as follows: “The Secretary may by order require a manufacturer to conduct postmarket surveillance for any device of the manufacturer which is a class II or class III device the failure of which would be reasonably likely to have serious adverse health consequences or which is intended to be—

“(1) implanted in the human body for more than one year, or

“(2) a life sustaining or life supporting device used outside a device user facility.”

Subsec. (b). Pub. L. 110–85, § 307(3), designated existing provisions as par. (1), inserted par. heading, substituted “Except as provided in paragraph (2), the Secretary, in consultation” for “The Secretary, in consultation” and “Except as provided in paragraph (2), any determination” for “Any determination”, and added par. (2).

Subsec. (c). Pub. L. 110–85, § 307(3)(D), added subsec. (c).

1997—Pub. L. 105–115 amended section generally, substituting present provisions for former provisions which related to required surveillance, discretionary surveillance, and surveillance approval.

1992—Subsec. (b). Pub. L. 102–300 substituted “(a)(1)” for “(a)”, inserted comma after “commerce”, and inserted after first sentence “Each manufacturer required to conduct a surveillance of a device under subsection (a)(2) of this section shall, within 30 days after receiving notice that the manufacturer is required to conduct such surveillance, submit, for the approval of the Secretary, a protocol for the required surveillance.”

### Statutory Notes and Related Subsidiaries

### Effective Date of 1997 Amendment

Pub. L. 105–115, title II, § 212, Nov. 21, 1997, 111 Stat. 2346, provided in part that the amendment made by that section is effective 90 days after Nov. 21, 1997.

### Study by Institute of Medicine of Postmarket Surveillance Regarding Pediatric Populations

Pub. L. 107–250, title II, § 212, Oct. 26, 2002, 116 Stat. 1614, as amended by Pub. L. 108–214, § 2(d)(3)(C), Apr. 1, 2004, 118 Stat. 577, provided that the Secretary of Health and Human Services would request the Institute of Medicine to study whether the system under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) for the postmarket surveillance of medical devices provides adequate safeguards regarding the use of devices in pediatric populations, and provided that the Secretary, not later than four years after Oct. 26, 2002, would submit to Congress a report on the study and legislative and administrative recommendations.