Fabio
76b8ec33a7
Ingested titles 12–51 and 54 from OLRC USLM XML @119-100 (the whole Code now, uniform edition; Title 53 is reserved/empty). LegalText 11,221 -> 59,740; repo total 105,704 records. Deterministic (byte-identical rerun, verified on Title 42's 8,356 sections); make check green. make legal-us-code default now covers every title. Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
64 lines
2.9 KiB
Markdown
64 lines
2.9 KiB
Markdown
---
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type: "LegalText"
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title: "21 U.S.C. § 360h–1"
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description: "Program to improve the device recall system"
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jurisdiction: "us"
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corpus: "united_states_code"
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kind: "code_section"
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title_number: 21
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title_name: "FOOD AND DRUGS"
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chapter_number: "9"
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chapter_name: "FEDERAL FOOD, DRUG, AND COSMETIC ACT"
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section: "360h–1"
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citation: "21 U.S.C. § 360h–1"
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status: "current"
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release_point: "119-100"
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release_date: "2026-06-26"
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source: "official"
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source_url: "https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip"
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source_identifier: "/us/usc/t21/s360h–1"
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source_file: "data/legal/raw/us/code/title-21/usc21.xml"
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source_hash: "eb289aa1a1f81501cd6259e048b2a25ff2ea859c1c1439a3774ed594d57f61bf"
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raw_snapshot_hash: "3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1"
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text_hash: "9be5b3eececd47f6b2faff88f183619a079f5cf9d8e0a8fef96171b37ac160dc"
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retrieved_at: "2026-07-04"
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confidence: "official"
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tags: ["legal", "us-code"]
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---
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# 21 U.S.C. § 360h–1 - Program to improve the device recall system
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## Text
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(a) In general The Secretary shall—
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(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;
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(2) clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner;
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(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
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(4) document the basis for each termination by the Food and Drug Administration of a device recall.
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(b) Assessment content The program established under subsection (a)(1) shall, at a minimum, identify—
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(1) trends in the number and types of device recalls;
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(2) devices that are most frequently the subject of a recall; and
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(3) underlying causes of device recalls.
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(c) Definition In this section, the term “recall” means—
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(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
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(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.
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(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.)
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## Notes
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Editorial Notes
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Amendments2016—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.”
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