View all text of Part A [§ 351 - § 360n-2]
§ 360l. Postmarket surveillance
(a) Postmarket surveillance
(1) In general
(A) ConductThe 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
(2) Rule of construction
(b) Surveillance approval
(1) In general
(2) Longer surveillance for pediatric devices
(c) Dispute resolution
(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.)