PRIA, Government Policy, Made Personal

Summary

The Secretary can require a device maker to do postmarket surveillance for any class II or class III device when the device’s failure could likely cause serious harm, when it will be used a lot in children, or when it is meant to be implanted more than 1 year or to keep someone alive or supported outside a care facility. The Secretary can impose this requirement when the device is approved or cleared, or at any time after. For devices expected to be used a lot in children, the Secretary can make the surveillance a condition of approval. If ordered to do surveillance, the manufacturer must send a surveillance plan to the Secretary within 30 days. The Secretary must decide within 60 days whether the plan and the people doing the work are qualified and whether the plan will gather useful safety data. The manufacturer must start the surveillance no later than 15 months after the order. The Secretary can require a prospective surveillance period up to 36 months; longer periods need agreement or a dispute process. For pediatric devices, the Secretary can order more than 36 months if needed to study growth and development effects. A manufacturer can seek review of the order, and while review is pending, not following the order won’t be treated as a legal violation unless needed to protect public health. This does not limit other legal authorities the agency has.

Title 21, §360l

Food and Drugs, Source: USLM XML via OLRC

(a)Postmarket surveillance

(1)In general

(A)Conduct

The Secretary may by order, at the time of approval or clearance of a device or at any time thereafter, require a manufacturer to conduct postmarket surveillance for any device of the manufacturer that is a class II or class III device—

(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 used outside a device user facility.

(B)Condition

The Secretary may order a postmarket surveillance under subparagraph (A) as a condition to approval or clearance of a device described in subparagraph (A)(ii).

(2)Rule of construction

The provisions of paragraph (1) shall have no effect on authorities otherwise provided under the chapter or regulations issued under this chapter.

(b)Surveillance approval

(1)In general

Each manufacturer required to conduct a surveillance of a device shall, within 30 days of receiving an order from the Secretary prescribing that the manufacturer is required under this section to conduct such surveillance, submit, for the approval of the Secretary, a plan for the required surveillance. The Secretary, within 60 days of the receipt of such plan, shall determine if the person 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 shall commence surveillance under this section not later than 15 months after the day on which the Secretary issues an order under this section. Except as provided in paragraph (2), the Secretary, in consultation with the manufacturer, may by order require a prospective surveillance period of up to 36 months. Except as provided in paragraph (2), any determination by the Secretary that a longer period is necessary shall be made by mutual agreement between the Secretary and the manufacturer or, if no agreement can be reached, after the completion of a dispute resolution process as described in section 360bbb–1 of this title.

(2)Longer surveillance for pediatric devices

The Secretary may by order require a prospective surveillance period of more than 36 months with respect to a device 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 on growth and development, or the effects of growth, development, activity level, or other factors on the safety or efficacy of the device.

(c)Dispute resolution

A manufacturer may request review under section 360bbb–1 of this title of any order or condition requiring postmarket surveillance under this section. During the pendency of such review, the device 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, adulterated under section 351(f)(1) of this title, misbranded under section 352(t)(3) of this title, or in violation of, as applicable, section 360(k) of this title or section 360e of this title, unless deemed necessary to protect the public health.

Notes & Related Subsidiaries

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.

§360l Postmarket Surveillance