POSTMARKET SURVEILLANCE.

SEC. 307. POSTMARKET SURVEILLANCE. Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) is amended—(1) by amending the section heading and designation to read as follows:“SEC. 522. POSTMARKET SURVEILLANCE.” ;(2) by striking subsection (a) and inserting the following:“(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 Act or regulations issued under this Act.”; and(3) in subsection (b)—(A) by striking “(b) Surveillance Approval.—Each” and inserting the following:“(b) Surveillance Approval.—121 STAT. 866“(1) In general.—Each”;(B) by striking “The Secretary, in consultation” and inserting “Except as provided in paragraph (2), the Secretary, in consultation”;(C) by striking “Any determination” and inserting “Except as provided in paragraph (2), any determination”; and(D) by adding at the end the following:“(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 562 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 301(q)(1)(C), adulterated under section 501(f)(1), misbranded under section 502(t)(3), or in violation of, as applicable, section 510(k) or section 515, unless deemed necessary to protect the public health.”.