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

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(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) Termination of recalls
The Secretary shall document the basis for the termination by the Food and Drug Administration of a device recall.
(d) 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) ofsection 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.

Source

(June 25, 1938, ch. 675, § 518A, as added Pub. L. 112–144, title VI, § 605,July 9, 2012, 126 Stat. 1053.)

This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.

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21 CFR - Food and Drugs

21 CFR Part 3 - PRODUCT JURISDICTION

21 CFR Part 4 - REGULATION OF COMBINATION PRODUCTS

21 CFR Part 5 - ORGANIZATION

21 CFR Part 7 - ENFORCEMENT POLICY

21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES

21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING

21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

21 CFR Part 20 - PUBLIC INFORMATION

21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

21 CFR Part 26 - MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY

21 CFR Part 50 - PROTECTION OF HUMAN SUBJECTS

21 CFR Part 54 - FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

21 CFR Part 56 - INSTITUTIONAL REVIEW BOARDS

21 CFR Part 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

21 CFR Part 71 - COLOR ADDITIVE PETITIONS

21 CFR Part 571 - FOOD ADDITIVE PETITIONS

21 CFR Part 610 - GENERAL BIOLOGICAL PRODUCTS STANDARDS

21 CFR Part 660 - ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS

21 CFR Part 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

21 CFR Part 810 - MEDICAL DEVICE RECALL AUTHORITY

21 CFR Part 812 - INVESTIGATIONAL DEVICE EXEMPTIONS

21 CFR Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES

21 CFR Part 820 - QUALITY SYSTEM REGULATION

21 CFR Part 821 - MEDICAL DEVICE TRACKING REQUIREMENTS

21 CFR Part 895 - BANNED DEVICES

21 CFR Part 897

21 CFR Part 1010 - PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

21 CFR Part 1020 - PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS

21 CFR Part 1030 - PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS

21 CFR Part 1040 - PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

21 CFR Part 1050 - PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS

 

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