POSTMARKET SURVEILLANCE.

SEC. 616. POSTMARKET SURVEILLANCE. Section 522 (21 U.S.C. 360l) is amended— (1) in subsection (a)(1)(A), in the matter preceding clause (i), by inserting “, at the time of approval or clearance of a device or at any time thereafter,” after “by order”; and (2) in subsection (b)(1), by inserting “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 second sentence.