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21 U.S.C. · Food and Drugs
21 U.S.C. § 360h1

Program to improve the device recall system

Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
Title 21 U.S.C. ● ACTIVE Primary Source Ch. 9
Statutory Text

21 U.S.C. § 360h1 — Program to improve the device recall system

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V - DRUGS AND DEVICES Part A - Drugs and Devices Sec. 360h-1 - Program to improve the device recall system From the U.S. Government Publishing Office, www.gpo.gov

§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) the removal from the market of a device pursuant to an order of the Secretary under subsection (b) or (e) of section 360h of this title; or (2) 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 section 360i(g) of this title.

(June 25, 1938, ch. 675, §518A, as added Pub. L. 112–144, title VI, §605, July 9, 2012, 126 Stat. 1053; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(K), Dec. 13, 2016, 130 Stat. 1154.)

Editorial Notes

Amendments 2016—Subsecs. (c), (d). Pub. L. 114–255 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."

Source: uscode.house.gov — public domain Official Source ↗
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BS-USC21-SEC-FECCAB
Entity Class
STATUTE / FEDERAL-CODE-SECTION
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boisestandard.org
Citation
21 U.S.C. § 360h1
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Federal — United States
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PRIMARY-SOURCE
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ae668704ccb0b738...
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The statutory text of 21 U.S.C. § 360h1 is reproduced from the official United States Code as published by the Office of the Law Revision Counsel of the U.S. House of Representatives (uscode.house.gov).
Navigate Corpus — Title 21
← 21 U.S.C. § 360h 21 U.S.C. § 360i →
Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
21 U.S.C. § 30121 U.S.C. § 32121 U.S.C. § 321a21 U.S.C. § 321b21 U.S.C. § 321c21 U.S.C. § 321d21 U.S.C. § 33121 U.S.C. § 33221 U.S.C. § 33321 U.S.C. § 333a21 U.S.C. § 33421 U.S.C. § 33521 U.S.C. § 335a21 U.S.C. § 335b21 U.S.C. § 335c21 U.S.C. § 33621 U.S.C. § 33721 U.S.C. § 337a21 U.S.C. § 34121 U.S.C. § 34221 U.S.C. § 34321 U.S.C. § 343121 U.S.C. § 343221 U.S.C. § 343321 U.S.C. § 343a21 U.S.C. § 34421 U.S.C. § 34521 U.S.C. § 34621 U.S.C. § 346a21 U.S.C. § 346b
21 U.S.C. — public domain ← All Legislation
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