Source: http://www4.law.cornell.edu/uscode/text/21/360h?quicktabs_8=4
Timestamp: 2013-12-10 15:00:02
Document Index: 78494312

Matched Legal Cases: ['§ 360', '§ 360', '§ 360', '§ 518', '§ 2', '§ 8', '§ 4', 'art 10', 'art 11', 'art 12', 'art 13', 'art 14', 'art 15', 'art 16', 'art 20', 'art 25', 'art 26', 'art 50', 'art 54', 'art 56', 'art 58', 'art 71', 'art 571', 'art 610', 'art 660', 'art 809', 'art 810', 'art 812', 'art 814', 'art 820', 'art 821', 'art 895', 'art 1010', 'art 1020', 'art 1030', 'art 1040', 'art 1050']

21 USC § 360h - Notification and other remedies | Title 21 - Food and Drugs | U.S. Code | LII / Legal Information Institute
USC › Title 21 › Chapter 9 › Subchapter V › Part A › § 360h	prevnext
21 USC § 360h - Notification and other remedies
The Secretary shall approve a plan submitted pursuant to an order issued under subparagraph (A) unless he determines (after affording opportunity for an informal hearing) that the action or actions to be taken under the plan or the manner in which such action or actions are to be taken under the plan will not assure that the unreasonable risk with respect to which such order was issued will be eliminated. If the Secretary disapproves a plan, he shall order a revised plan to be submitted to him within a reasonable time. If the Secretary determines (after affording opportunity for an informal hearing) that the revised plan is unsatisfactory or if no revised plan or no initial plan has been submitted to the Secretary within the prescribed time, the Secretary shall (i)
prescribe a plan to be carried out by the person or persons to whom the order issued under subparagraph (A) was directed, or (ii)
after affording an opportunity for an informal hearing, by order prescribe a plan to be carried out by a person who is a manufacturer, importer, distributor, or retailer of the device with respect to which the order was issued but to whom the order under subparagraph (A) was not directed.
The actions which may be taken under a plan submitted under an order issued under paragraph (1) are as follows:
To refund the purchase price of the device (less a reasonable allowance for use if such device has been in the possession of the device user for one year or more—
Reimbursement An order issued under subsection (b) of this section with respect to a device may require any person who is a manufacturer, importer, distributor, or retailer of the device to reimburse any other person who is a manufacturer, importer, distributor, or retailer of such device for such other person’s expenses actually incurred in connection with carrying out the order if the Secretary determines such reimbursement is required for the protection of the public health. Any such requirement shall not affect any rights or obligations under any contract to which the person receiving reimbursement or the person making such reimbursement is a party.
Effect on other liability Compliance with an order issued under this section shall not relieve any person from liability under Federal or State law. In awarding damages for economic loss in an action brought for the enforcement of any such liability, the value to the plaintiff in such action of any remedy provided him under such order shall be taken into account.
If the Secretary finds that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the device)—
In providing the notice required by clause (ii), the Secretary may use the assistance of health professionals who prescribed or used such a device for individuals. If a significant number of such individuals cannot be identified, the Secretary shall notify such individuals pursuant to section 375
(June 25, 1938, ch. 675, § 518, as added Pub. L. 94–295, § 2,May 28, 1976, 90 Stat. 562; amended Pub. L. 101–629, § 8,Nov. 28, 1990, 104 Stat. 4520; Pub. L. 102–300, § 4,June 16, 1992, 106 Stat. 239.)
1992—Subsec. (b)(1)(A)(ii). Pub. L. 102–300substituted “or” for “and” after “properly designed” and “time of its design”.
1990—Subsec. (e). Pub. L. 101–629added subsec. (e).
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 3 - PRODUCT JURISDICTION21 CFR 5 - ORGANIZATION21 CFR 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 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 MEDICAL 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 571 - FOOD ADDITIVE PETITIONS21 CFR Part 610 - GENERAL BIOLOGICAL PRODUCTS STANDARDS21 CFR Part 660 - ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS21 CFR Part 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE21 CFR Part 810 - MEDICAL DEVICE RECALL AUTHORITY21 CFR Part 812 - INVESTIGATIONAL DEVICE EXEMPTIONS21 CFR Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES21 CFR Part 820 - QUALITY SYSTEM REGULATION21 CFR Part 821 - MEDICAL DEVICE TRACKING REQUIREMENTS21 CFR Part 895 - BANNED DEVICES21 CFR 89721 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