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21 U.S. Code § 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
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).