U.S. CODE

U.S. Code

§ 360l. Postmarket surveillance

(a) Postmarket surveillance

(1) In general

(A) Conduct

The Secretary may by order 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 ^[1] 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. 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.

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.

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

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