21 U.S.C. § 360h–1 | Program to improve the device recall system

(a)

In general

The Secretary shall—

(1)

establish a program to routinely and systematically assess information relating to device recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices;

(2)

clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner;

(3)

develop detailed criteria for assessing whether a person performing a device recall has performed an effective correction or action plan for the recall; and

(4)

document the basis for each termination by the Food and Drug Administration of a device recall.

(b)

Assessment content

The program established under subsection (a)(1) shall, at a minimum, identify—

(1)

trends in the number and types of device recalls;

(2)

devices that are most frequently the subject of a recall; and

(3)

underlying causes of device recalls.

(c)

Definition

In this section, the term “recall” means—

(1)

section 360h of this title the removal from the market of a device pursuant to an order of the Secretary under subsection (b) or (e) of ; or

(2)

section 360i(g) of this title the correction or removal from the market of a device at the initiative of the manufacturer or importer of the device that is required to be reported to the Secretary under .

June 25, 1938, ch. 675, § 518A Pub. L. 112–144, title VI, § 605July 9, 2012126 Stat. 1053 Pub. L. 114–255, div. A, title III, § 3101(a)(2)(K)Dec. 13, 2016130 Stat. 1154(, as added , , ; amended , , .)

Editorial Notes

Amendments

Pub. L. 114–2552016—Subsecs. (c), (d). redesignated subsec. (d) as (c) and struck out former subsec. (c). Prior to amendment, text read as follows: “The Secretary shall document the basis for the termination by the Food and Drug Administration of a device recall.”