Source: http://www4.law.cornell.edu/uscode/text/21/360j?quicktabs_8=4
Timestamp: 2013-12-10 18:18:46
Document Index: 29570183

Matched Legal Cases: ['§ 360', '§ 360', '§ 360', '§ 107', '§ 125', '§ 201', '§ 410', '§ 1', '§ 303', '§ 801', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360']

21 USC § 360j - General provisions respecting control of devices intended for human use | Title 21 - Food and Drugs | U.S. Code | LII / Legal Information Institute
USC › Title 21 › Chapter 9 › Subchapter V › Part A › § 360j	prevnext
21 USC § 360j - General provisions respecting control of devices intended for human use
Custom devices Sections 360d and 360e of this title do not apply to any device which, in order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing) necessarily deviates from an otherwise applicable performance standard or requirement prescribed by or under section 360e of this title if (1)
the device is not generally available in finished form for purchase or for dispensing upon prescription and is not offered through labeling or advertising by the manufacturer, importer, or distributor thereof for commercial distribution, and (2)
such device—
is intended for use by an individual patient named in such order of such physician or dentist (or other specially qualified person so designated) and is to be made in a specific form for such patient, or
is intended to meet the special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of such physician or dentist (or other specially qualified person so designated), and
is not generally available to or generally used by other physicians or dentists (or other specially qualified persons so designated).
A requirement that the person applying for an exemption for a device assure the establishment and maintenance of such records, and the making of such reports to the Secretary of data obtained as a result of the investigational use of the device during the exemption, as the Secretary determines will enable him to assure compliance with such conditions, review the progress of the investigation, and evaluate the safety and effectiveness of the device.
The device with respect to which the exemption is granted is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs.
The device was not previously approved under this subsection for the pediatric patients or the pediatric subpopulation described in subclause (I) prior to September 27, 2007.
During any calendar year, the number of such devices distributed during that year does not exceed the annual distribution number specified by the Secretary when the Secretary grants such exemption. The annual distribution number shall be based on the number of individuals affected by the disease or condition that such device is intended to treat, diagnose, or cure, and of that number, the number of individuals likely to use the device, and the number of devices reasonably necessary to treat such individuals. In no case shall the annual distribution number exceed the number identified in paragraph (2)(A).
The request for such exemption is submitted on or before October 1, 2012.
A person may petition the Secretary to modify the annual distribution number specified by the Secretary under subparagraph (A)(ii) with respect to a device if additional information on the number of individuals affected by the disease or condition arises, and the Secretary may modify such number but in no case shall the annual distribution number exceed the number identified in paragraph (2)(A).
The Secretary shall refer any report of an adverse event regarding a device for which the prohibition under paragraph (3) does not apply pursuant to paragraph (6)(A) that the Secretary receives to the Office of Pediatric Therapeutics, established under section 393a of this title. In considering the report, the Director of the Office of Pediatric Therapeutics, in consultation with experts in the Center for Devices and Radiological Health, shall provide for periodic review of the report by the Pediatric Advisory Committee, including obtaining any recommendations of such committee regarding whether the Secretary should take action under this chapter in response to the report.
The Secretary, acting through the Office of Pediatric Therapeutics and the Center for Devices and Radiological Health, shall provide for an annual review by the Pediatric Advisory Committee of all devices described in paragraph (6) to ensure that the exemption under paragraph (2) remains appropriate for the pediatric populations for which it is granted.
(e), (f),Nov. 28, 1990, 104 Stat. 4514, 4516, 4518, 4519, 4522, 4524, 4529; Pub. L. 102–571, title I, § 107(10),Oct. 29, 1992, 106 Stat. 4499; Pub. L. 105–115, title I, § 125(b)(2)(E), title II, §§ 201(a), 203, 216(a)(1), title IV, § 410(a),Nov. 21, 1997, 111 Stat. 2325, 2332, 2334, 2349, 2372; Pub. L. 109–96, § 1,Nov. 9, 2005, 119 Stat. 2119; Pub. L. 110–85, title III, § 303(a), title VIII, § 801(b)(3)(E),Sept. 27, 2007, 121 Stat. 860, 921.)
Section 14(b) ofPub. L. 101–629provided that: “Subsection (m) ofsection 520 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360j
Section 14(c) ofPub. L. 101–629directed Secretary of Health and Human Services, within 4 years after issuance of regulations under 21 U.S.C. 360j
21 USCDescription of ChangeSession YearPublic LawStatutes at Large § 360j2012112-144 [Sec.] 617126 Stat. 1062 § 360jnt new2012112-144 [Sec.] 613(b)126 Stat. 1061 § 360j2012112-144 [Sec.] 613(a)126 Stat. 1060 § 360j2012112-144 [Sec.] 606126 Stat. 1054 § 360j2012112-144 [Sec.] 601126 Stat. 1051 § 360j2012112-144 [Sec.] 507(c)126 Stat. 1045 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 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES21 CFR 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES21 CFR 12 - FORMAL EVIDENTIARY PUBLIC HEARING21 CFR 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY21 CFR 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE21 CFR 15 - PUBLIC HEARING BEFORE THE COMMISSIONER21 CFR 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION21 CFR 17 - CIVIL MONEY PENALTIES HEARINGS21 CFR 20 - PUBLIC INFORMATION21 CFR 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS21 CFR 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 50 - PROTECTION OF HUMAN SUBJECTS21 CFR 54 - FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS21 CFR 56 - INSTITUTIONAL REVIEW BOARDS21 CFR 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES21 CFR 60 - PATENT TERM RESTORATION21 CFR 71 - COLOR ADDITIVE PETITIONS21 CFR 201 - LABELING21 CFR 310 - NEW DRUGS21 CFR 606 - CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS21 CFR 801 - LABELING21 CFR 803 - MEDICAL DEVICE REPORTING21 CFR 806 - MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS21 CFR 807 - ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES21 CFR 808 - EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS21 CFR 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE21 CFR 812 - INVESTIGATIONAL DEVICE EXEMPTIONS21 CFR 814 - PREMARKET APPROVAL OF MEDICAL DEVICES21 CFR 820 - QUALITY SYSTEM REGULATION21 CFR 860 - MEDICAL DEVICE CLASSIFICATION PROCEDURES21 CFR 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES21 CFR 864 - HEMATOLOGY AND PATHOLOGY DEVICES21 CFR 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES21 CFR 868 - ANESTHESIOLOGY DEVICES21 CFR 870 - CARDIOVASCULAR DEVICES21 CFR 89721 CFR 1010 - PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL21 CFR 1020 - PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS21 CFR 1030 - PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS21 CFR 1040 - PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS21 CFR 1050 - PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS
87 CFR - 87 CFR 87687 CFR 87887 CFR 88087 CFR 88287 CFR 88487 CFR 88687 CFR 88887 CFR 89087 CFR 89287 CFR 1002