Source: https://www.law.cornell.edu/uscode/text/21/360f?quicktabs_8=2
Timestamp: 2015-05-04 13:45:19
Document Index: 52408361

Matched Legal Cases: ['§ 360', '§ 360', '§ 360', '§ 516', '§ 2', '§ 18', 'art 3', 'art 4', 'art 5', 'art 7', 'art 10', 'art 11', 'art 12', 'art 13', 'art 14', 'art 15', 'art 16', 'art 17', 'art 20', 'art 25', 'art 26', 'art 50', 'art 54', 'art 56', 'art 58', 'art 71', 'art 310', 'art 570', 'art 571', 'art 812', 'art 814', 'art 895', 'art 1010', 'art 1020', 'art 1030', 'art 1040', 'art 1050']

21 U.S. Code § 360f - Banned devices | LII / Legal Information Institute
U.S. Code › Title 21 › Chapter 9 › Subchapter V › Part A › § 360f 21 U.S. Code § 360f - Banned devices
General rule Whenever the Secretary finds, on the basis of all available data and information, that—
a device intended for human use presents substantial deception or an unreasonable and substantial risk of illness or injury; and
Special effective date The Secretary may declare a proposed regulation under subsection (a) of this section to be effective upon its publication in the Federal Register and until the effective date of any final action taken respecting such regulation if (1)
he determines, on the basis of all available data and information, that the deception or risk of illness or injury associated with the use of the device which is subject to the regulation presents an unreasonable, direct, and substantial danger to the health of individuals, and (2)
before the date of the publication of such regulation, the Secretary notifies the manufacturer of such device that such regulation is to be made so effective. If the Secretary makes a proposed regulation so effective, he shall, as expeditiously as possible, give interested persons prompt notice of his action under this subsection, provide reasonable opportunity for an informal hearing on the proposed regulation, and either affirm, modify, or revoke such proposed regulation.
(June 25, 1938, ch. 675, § 516, as added Pub. L. 94–295, § 2,May 28, 1976, 90 Stat. 560; amended Pub. L. 101–629, § 18(d),Nov. 28, 1990, 104 Stat. 4529.)
1990—Subsec. (a). Pub. L. 101–629struck out “and after consultation with the appropriate panel or panels under section 360c of this title” after “data and information” in introductory provisions and struck out at end “The Secretary shall afford all interested persons opportunity for an informal hearing on a regulation proposed under this subsection.”
This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.21 CFR - Food and Drugs21 CFR Part 3 - PRODUCT JURISDICTION21 CFR Part 4 - REGULATION OF COMBINATION PRODUCTS21 CFR Part 5 - ORGANIZATION21 CFR Part 7 - ENFORCEMENT POLICY21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION21 CFR Part 17 - CIVIL MONEY PENALTIES HEARINGS21 CFR Part 20 - PUBLIC INFORMATION21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS21 CFR Part 26 - MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY21 CFR Part 50 - PROTECTION OF HUMAN SUBJECTS21 CFR Part 54 - FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS21 CFR Part 56 - INSTITUTIONAL REVIEW BOARDS21 CFR Part 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES21 CFR Part 71 - COLOR ADDITIVE PETITIONS21 CFR Part 310 - NEW DRUGS21 CFR Part 570 - FOOD ADDITIVES21 CFR Part 571 - FOOD ADDITIVE PETITIONS21 CFR Part 812 - INVESTIGATIONAL DEVICE EXEMPTIONS21 CFR Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES21 CFR Part 895 - BANNED DEVICES21 CFR Part 1010 - PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL21 CFR Part 1020 - PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS21 CFR Part 1030 - PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS21 CFR Part 1040 - PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS21 CFR Part 1050 - PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS