21 USC 360l - Postmarket surveillance

U.S Code last checked for updates: Nov 22, 2024

§ 360l.

Postmarket surveillance

(a)

Postmarket surveillance

(1)

In general

(A)

Conduct

The 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.)

cite as: 21 USC 360l