Source: http://www.law.cornell.edu/uscode/text/21/360j?qt-us_code_tabs=0
Timestamp: 2014-10-21 22:38:55
Document Index: 29713114

Matched Legal Cases: ['§ 125', '§ 520', '§ 2', '§ 3', '§ 107', '§ 125', '§ 201', '§ 410', '§ 1', '§ 303', '§ 801', '§ 507', '§ 601', '§ 617', '§ 601', '§ 601', '§ 606', '§ 613', '§ 613', '§ 507', '§ 613', '§ 613', '§ 613', '§ 801', '§ 303', '§ 303', '§ 303', '§ 410', '§ 201', '§ 216', '§ 125', '§ 125', '§ 203', '§ 203', '§ 203', '§ 203', '§ 203', '§ 11', '§ 18', '§ 11', '§ 11', '§ 6', '§ 3', '§ 18', '§ 5', '§ 4', '§ 14', '§ 14', '§ 613', '§ 303', '§ 213', '§ 14', '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 60', 'art 71', 'art 310', 'art 606', 'art 801', 'art 803', 'art 806', 'art 807', 'art 808', 'art 809', 'art 810', 'art 812', 'art 814', 'art 820', 'art 83021', 'art 860', 'art 862', 'art 864', 'art 866', 'art 868', 'art 870', 'art 872', 'art 876', 'art 878', 'art 880', 'art 882', 'art 884', 'art 886', 'art 888', 'art 890', 'art 892', 'art 89721', 'art 1002', 'art 1010', 'art 1020', 'art 1030', 'art 1040', 'art 1050']

Notices and findings Each notice of proposed rulemaking under section 360c, 360d, 360e, 360f, 360h, or 360i of this title, or under this section, any other notice which is published in the Federal Register with respect to any other action taken under any such section and which states the reasons for such action, and each publication of findings required to be made in connection with rulemaking under any such section shall set forth—
Restricted devices (1)
The Secretary may by regulation require that a device be restricted to sale, distribution, or use—
Good manufacturing practice requirements (1)
Before the Secretary may promulgate any regulation under subparagraph (A) he shall—
Any person subject to any requirement prescribed by regulations under paragraph (1) may petition the Secretary for an exemption or variance from such requirement. Such a petition shall be submitted to the Secretary in such form and manner as he shall prescribe and shall—
The Secretary may refer to the advisory committee established under paragraph (3) any petition submitted under subparagraph (A). The advisory committee shall report its recommendations to the Secretary with respect to a petition referred to it within sixty days of the date of the petition’s referral. Within sixty days after—
The Secretary shall establish an advisory committee for the purpose of advising and making recommendations to him with respect to regulations proposed to be promulgated under paragraph (1)(A) and the approval or disapproval of petitions submitted under paragraph (2). The advisory committee shall be composed of nine members as follows:
Exemption for devices for investigational use (1)
The conditions prescribed pursuant to subparagraph (A) shall include the following:
Procedures and conditions prescribed pursuant to subparagraph (A) for an exemption may appropriately vary depending on (i)
the scope and duration of clinical testing to be conducted under such exemption, (ii)
the number of human subjects that are to be involved in such testing, (iii)
the need to permit changes to be made in the device subject to the exemption during testing conducted in accordance with a clinical testing plan required under paragraph (3)(A), and (iv) whether the clinical testing of such device is for the purpose of developing data to obtain approval for the commercial distribution of such device.
Procedures and conditions prescribed pursuant to paragraph (2)(A) shall require, as a condition to the exemption of any device to be the subject of testing involving human subjects, that the person applying for the exemption—
submit a plan for any proposed clinical testing of the device and a report of prior investigations of the device (including, where appropriate, tests on animals) adequate to justify the proposed clinical testing—
to the Secretary, if—
Consistent with paragraph (1), the Secretary shall not disapprove an application under this subsection because the Secretary determines that—
Not later than 1 year after November 21, 1997, the Secretary shall by regulation establish, with respect to a device for which an exemption under this subsection is in effect, procedures and conditions that, without requiring an additional approval of an application for an exemption or the approval of a supplement to such an application, permit—
changes or modifications to clinical protocols that do not affect—
Regulations under subparagraph (A) shall provide that a change or modification described in such subparagraph may be made if—
Any agreement regarding the parameters of an investigational plan (including a clinical protocol) that is reached between the Secretary and a sponsor or applicant shall be reduced to writing and made part of the administrative record by the Secretary. Any such agreement shall not be changed, except—
For purposes of subparagraph (A), a determination described in this subparagraph with respect to a clinical hold is a determination that—
Release of information respecting safety and effectiveness (1)
The Secretary shall promulgate regulations under which a detailed summary of information respecting the safety and effectiveness of a device which information was submitted to the Secretary and which was the basis for—
an order under section 360e
(d)(1)(A) of this title approving an application for premarket approval for the device or denying approval of such an application or an order under section 360e
(e) of this title withdrawing approval of such an application for the device,
(f)(6)(A) of this title revoking an approved protocol for the device, an order under section 360e
(f)(6)(B) of this title declaring a protocol for the device completed or not completed, or an order under section 360e
(f)(7) of this title revoking the approval of the device, or
The Secretary shall promulgate regulations under which each advisory committee established under section 360e
(g)(2)(B) of this title shall make available to the public a detailed summary of information respecting the safety and effectiveness of a device which information was submitted to the advisory committee and which was the basis for its recommendation to the Secretary made pursuant to section 360e
(g)(2)(A) of this title. A summary of information upon which such a recommendation is based shall be made available pursuant to this paragraph only after the issuance of the order with respect to which the recommendation was made and each summary shall include information respecting any adverse effect on health of the device subject to such order.
Any information contained in an application for premarket approval filed with the Secretary pursuant to section 360e
(c) of this title (including information from clinical and preclinical tests or studies that demonstrate the safety and effectiveness of a device, but excluding descriptions of methods of manufacture and product composition and other trade secrets) shall be available, 6 years after the application has been approved by the Secretary, for use by the Secretary in—
Proceedings of advisory panels and committees Each panel under section 360c of this title and each advisory committee established under section 360d
(b)(5)(B) or 360e
(g) of this title or under subsection (f) of this section shall make and maintain a transcript of any proceeding of the panel or committee. Each such panel and committee shall delete from any transcript made pursuant to this subsection information which under subsection (c) of this section is to be considered confidential.
Traceability Except as provided in section 360i
(e) of this title, no regulation under this chapter may impose on a type or class of device requirements for the traceability of such type or class of device unless such requirements are necessary to assure the protection of the public health.
Research and development The Secretary may enter into contracts for research, testing, and demonstrations respecting devices and may obtain devices for research, testing, and demonstration purposes without regard to section 3324
Transitional provisions for devices considered as new drugs (1)
Any device intended for human use—
for which on May 28, 1976 (hereinafter in this subsection referred to as the “enactment date”) an approval of an application submitted under section 355
(b) of this title was in effect;
with respect to which on the enactment date an action is pending in a United States court under section 332, 333, or 334 of this title for an alleged violation of a provision of section 331 of this title which enforces a requirement of section 355 of this title or for an alleged violation of section 355
The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer or importer of a device classified under paragraph (1) may petition the Secretary (in such form and manner as he shall prescribe) for the issuance of an order classifying the device in class I or class II. Within thirty days of the filing of such a petition, the Secretary shall notify the petitioner of any deficiencies in the petition which prevent the Secretary from making a decision on the petition. Except as provided in paragraph (3)(D)(ii), within one hundred and eighty days after the filing of a petition under this paragraph, the Secretary shall, after consultation with the appropriate panel under section 360c of this title, by order either deny the petition or order the classification, in accordance with the criteria prescribed by section 360c
(a)(1)(A) of this title or 360c(a)(1)(B) of this title, of the device in class I or class II.
In the case of a device which is described in paragraph (1)(A) and which is in class III—
In the case of a device which is described in paragraph (1)(B) and which is in class III, an application for such device shall be considered as having been filed under section 360e of this title on the enactment date. The period in which the Secretary shall act on such application in accordance with section 360e
(d)(1) of this title shall be one hundred and eighty days from the enactment date (or such greater period as the Secretary and the applicant may agree upon after the Secretary has made the finding required by section 360e
(d)(1)(B)(i) of this title) less the number of days in the period beginning on the date an application for such device was filed under section 355 of this title and ending on the enactment date. After the expiration of such period such device is required, unless exempt under subsection (g) of this section, to have in effect an approved application under section 360e of this title.
within the sixty-day period beginning on the enactment date (or within such greater period as the Secretary, after making the finding required under section 360e
(d)(1)(B) of this title, and the petitioner or applicant may agree upon), the Secretary shall act on such petition or application in accordance with paragraph (2) or section 360e of this title except that the period within which the Secretary must act on the petition or application shall be within the one hundred and twenty-day period beginning on the date the petition or application is filed. If such a petition or application is filed within such sixty-day (or greater) period, clause (i) of this subparagraph shall not apply to such device before the expiration of such one hundred and twenty-day period, or if such petition is denied or such application is denied approval, before the date of such denial, whichever occurs first.
In the case of a device which is described in subparagraph (E) of paragraph (1), which the Secretary in a notice published in the Federal Register after March 31, 1976, declared to be a new drug subject to section 355 of this title, and which is in class III—
Repealed. Pub. L. 105–115, title I, § 125(b)(2)(E),Nov. 21, 1997, 111 Stat. 2325.
Except as provided in subparagraph (C), after the issuance of an order under subparagraph (A) but before December 1, 1992, the Secretary shall publish a regulation in the Federal Register for each device which is classified in class III under paragraph (1) revising the classification of the device so that the device is classified into class I or class II, unless the regulation requires the device to remain in class III. In determining whether to revise the classification of a device or to require a device to remain in class III, the Secretary shall apply the criteria set forth in section 360c
(a) of this title. Before the publication of a regulation requiring a device to remain in class III or revising its classification, the Secretary shall publish a proposed regulation respecting the classification of a device under this subparagraph and provide an opportunity for the submission of comments on any such regulation. No regulation under this subparagraph requiring a device to remain in class III or revising its classification may take effect before the expiration of 90 days from the date of the publication in the Federal Register of the proposed regulation.
Humanitarian device exemption (1)
The Secretary may grant a request for an exemption from the effectiveness requirements of sections 360d and 360e of this title for a device for which the Secretary finds that—
The request shall be in the form of an application submitted to the Secretary and such application shall include the certification required under section 282
(j)(5)(B) of title 42 (which shall not be considered an element of such application). Not later than 75 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application.
Devices granted an exemption under paragraph (2) may only be used—
Except as provided in subparagraph (D), the prohibition in paragraph (3) shall not apply with respect to a person granted an exemption under paragraph (2) if each of the following conditions apply:
The device with respect to which the exemption is granted—
In this subsection, the term “pediatric subpopulation” means 1 of the following populations:
Regulation of contact lenses as devices (1)
All contact lenses shall be deemed to be devices under section 321
Paragraph (1) shall not be construed as bearing on or being relevant to the question of whether any product other than a contact lens is a device as defined by section 321
(h) of this title or a drug as defined by section 321
(June 25, 1938, ch. 675, § 520, as added Pub. L. 94–295, § 2,May 28, 1976, 90 Stat. 565; amended Pub. L. 101–629, §§ 3(b)(2), 4
(c)(2), 6
(b)(2), 11, 14
(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; Pub. L. 112–144, title V, § 507(c), title VI, §§ 601, 606, 613
(a), 617,July 9, 2012, 126 Stat. 1045, 1051, 1054, 1060, 1062.)
Section 14 of the Federal Advisory Committee Act, referred to in subsec. (f)(3), is section 14 ofPub. L. 92–463, which is set out in the Appendix to Title 5, Government Organization and Employees.
In subsec. (k), “section 3324
2012—Subsec. (b). Pub. L. 112–144, § 617, amended subsec. (b) generally. Prior to amendment, subsec. (b) related to custom devices.
Subsec. (g)(2)(B)(ii). Pub. L. 112–144, § 601(1), inserted “safety or effectiveness” before “data obtained”.
Subsec. (g)(4)(C). Pub. L. 112–144, § 601(2), added subpar. (C).
Subsec. (g)(8). Pub. L. 112–144, § 606, added par. (8).
Subsec. (m)(6)(A)(i). Pub. L. 112–144, § 613(a)(1)(A)(i), added cl. (i) and struck out former cl. (i) which read as follows:
Subsec. (m)(6)(A)(ii). Pub. L. 112–144, § 613(a)(1)(A)(ii), added cl. (ii) and struck out former cl. (ii) which read as follows: “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).”
Subsec. (m)(6)(A)(iv). Pub. L. 112–144, § 507(c), substituted “2017” for “2012”.
Subsec. (m)(6)(C). Pub. L. 112–144, § 613(a)(1)(B), amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: “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).”
Subsec. (m)(7). Pub. L. 112–144, § 613(a)(2), substituted “regarding a device described in paragraph (6)(A)(i)(I)” for “regarding a device”.
Subsec. (m)(8). Pub. L. 112–144, § 613(a)(3), substituted “of all devices described in paragraph (6)(A)(i)(I)” for “of all devices described in paragraph (6)”.
2007—Subsec. (m)(2). Pub. L. 110–85, § 801(b)(3)(E), inserted before period at end of first sentence of concluding provisions “and such application shall include the certification required under section 282
(j)(5)(B) of title 42 (which shall not be considered an element of such application)”.
Subsec. (m)(3). Pub. L. 110–85, § 303(a)(1), substituted “Except as provided in paragraph (6), no” for “No”.
Subsec. (m)(5). Pub. L. 110–85, § 303(a)(2), inserted “, if the Secretary has reason to believe that the requirements of paragraph (6) are no longer met,” after “public health” and inserted at end “If the person granted an exemption under paragraph (2) fails to demonstrate continued compliance with the requirements of this subsection, the Secretary may suspend or withdraw the exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after providing notice and an opportunity for an informal hearing.”
Subsec. (m)(6) to (8). Pub. L. 110–85, § 303(a)(3), added pars. (6) to (8) and struck out former par. (6) which read as follows: “The Secretary may suspend or withdraw an exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after providing notice and an opportunity for an informal hearing.”
2005—Subsec. (n). Pub. L. 109–96added subsec. (n).
1997—Subsec. (f)(1)(B)(iii). Pub. L. 105–115, § 410(a), added cl. (iii).
Subsec. (g)(6), (7). Pub. L. 105–115, § 201(a), added pars. (6) and (7).
Subsec. (h)(4). Pub. L. 105–115, § 216(a)(1), amended par. (4) generally. Prior to amendment, par. (4) related to premarket approval of devices.
Subsec. (l). Pub. L. 105–115, § 125(b)(2)(E), struck out “or antibiotic drugs” after “new drugs” in heading.
Subsec. (l)(4). Pub. L. 105–115, § 125(b)(2)(E), struck out par. (4) which read as follows: “Any device intended for human use which on the enactment date was subject to the requirements of section 357 of this title shall be subject to such requirements as follows:
Subsec. (m)(2). Pub. L. 105–115, § 203(1), inserted at end “The request shall be in the form of an application submitted to the Secretary. Not later than 75 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application.”
Subsec. (m)(4). Pub. L. 105–115, § 203(2)(B), inserted at end “In a case described in subparagraph (B) in which a physician uses a device without an approval from an institutional review committee, the physician shall, after the use of the device, notify the chairperson of the local institutional review committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.”
Subsec. (m)(4)(B). Pub. L. 105–115, § 203(2)(A), inserted before period at end “, unless a physician determines in an emergency situation that approval from a local institutional review committee can not be obtained in time to prevent serious harm or death to a patient”.
Subsec. (m)(5). Pub. L. 105–115, § 203(3), amended par. (5) generally. Prior to amendment, par. (5) read as follows: “An exemption under paragraph (2) shall be for a term of 18 months and may only be initially granted in the 5-year period beginning on the date regulations under paragraph (6) take effect. The Secretary may extend such an exemption for a period of 18 months if the Secretary is able to make the findings set forth in paragraph (2) and if the applicant supplies information demonstrating compliance with paragraph (3). An exemption may be extended more than once and may be extended after the expiration of such 5-year period.”
Subsec. (m)(6). Pub. L. 105–115, § 203(4), amended par. (6) generally. Prior to amendment, par. (6) read as follows: “Within one year of November 28, 1990, the Secretary shall issue regulations to implement this subsection.”
1992—Subsec. (g)(2)(A). Pub. L. 102–571substituted “379e” for “376”.
1990—Subsec. (c). Pub. L. 101–629, § 11(1), substituted “from class III to class II or class I” for “under section 360c of this title from class III to class II” and inserted “(1) in accordance with subsection (h) of this section, and (2)” after “except”.
Subsec. (f)(1)(A). Pub. L. 101–629, § 18(e), inserted “pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device),” after “manufacture,”.
Subsec. (h)(3). Pub. L. 101–629, § 11(2)(A), substituted “Except as provided in paragraph (4), any” for “Any”.
Subsec. (h)(4). Pub. L. 101–629, § 11(2)(B), added par. (4).
Subsec. (i). Pub. L. 101–629, § 6(b)(2), substituted “section 360d
(b)(5)(B)” for “section 360d
(g)(5)(B)”.
Subsec. (j). Pub. L. 101–629, § 3(b)(2), substituted “Except as provided in section 360i
(e) of this title, no” for “No”.
Subsec. (l)(2). Pub. L. 101–629, § 18(f), struck out “and after affording the petitioner an opportunity for an informal hearing” after “under this paragraph”.
Pub. L. 101–629, § 5(c)(2), substituted “The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer” for “The manufacturer”.
Subsec. (l)(5). Pub. L. 101–629, § 4(b)(2), added par. (5).
Subsec. (m). Pub. L. 101–629, § 14(a), added subsec. (m).
Amendment by sections 201(a), 203, 216(a)(1), and 410(a) ofPub. L. 105–115effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 ofPub. L. 105–115, set out as a note under section 321 of this title.
Pub. L. 101–629, § 14(b),Nov. 28, 1990, 104 Stat. 4525, provided that: “Subsection (m) ofsection 520 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360j
(m)], as added by the amendment made by subsection (a), shall take effect on the effective date of the regulations issued by the Secretary under paragraph (6) of such subsection.”
Pub. L. 112–144, title VI, § 613(b),July 9, 2012, 126 Stat. 1061, provided that: “A sponsor of a device for which an exemption was approved under paragraph (2) of section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j
(m)) before the date of enactment of this Act [July 9, 2012] may seek a determination under subclause (I) or (II) of section 520(m)(6)(A)(i) (as amended by subsection (a)). If the Secretary of Health and Human Services determines that such subclause (I) or (II) applies with respect to a device, clauses (ii), (iii), and (iv) of subparagraph (A) and subparagraphs (B), (C), (D), and (E) of paragraph (6) of such section 520(m) shall apply to such device, and the Secretary shall determine the annual distribution number for purposes of clause (ii) of such subparagraph (A) when making the determination under this subsection.”
Pub. L. 110–85, title III, § 303(c),Sept. 27, 2007, 121 Stat. 862, provided that: “Not later than 180 days after the date of the enactment of this Act [Sept. 27, 2007], the Commissioner of Food and Drugs shall issue guidance for institutional review committees on how to evaluate requests for approval for devices for which a humanitarian device exemption under section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j
(m)(2)) has been granted.”
Pub. L. 107–250, title II, § 213,Oct. 26, 2002, 116 Stat. 1614, provided that: “Not later than 270 days after the date of the enactment of this Act [Oct. 26, 2002], the Secretary of Health and Human Services shall issue guidance on the following:
“(1) The type of information necessary to provide reasonable assurance of the safety and effectiveness of medical devices intended for use in pediatric populations.
“(2) Protections for pediatric subjects in clinical investigations of the safety or effectiveness of such devices.”
Pub. L. 101–629, § 14(c),Nov. 28, 1990, 104 Stat. 4525, directed Secretary of Health and Human Services, within 4 years after issuance of regulations under 21 U.S.C. 360j
(m)(6), to report to Congress on types of devices exempted, an evaluation of effects of such section, and a recommendation on extension of the section.
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 60 - PATENT TERM RESTORATION21 CFR Part 71 - COLOR ADDITIVE PETITIONS21 CFR Part 310 - NEW DRUGS21 CFR Part 606 - CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS21 CFR Part 801 - LABELING21 CFR Part 803 - MEDICAL DEVICE REPORTING21 CFR Part 806 - MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS21 CFR Part 807 - ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES21 CFR Part 808 - EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS21 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 83021 CFR Part 860 - MEDICAL DEVICE CLASSIFICATION PROCEDURES21 CFR Part 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES21 CFR Part 864 - HEMATOLOGY AND PATHOLOGY DEVICES21 CFR Part 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES21 CFR Part 868 - ANESTHESIOLOGY DEVICES21 CFR Part 870 - CARDIOVASCULAR DEVICES21 CFR Part 872 - DENTAL DEVICES21 CFR Part 876 - GASTROENTEROLOGY-UROLOGY DEVICES21 CFR Part 878 - GENERAL AND PLASTIC SURGERY DEVICES21 CFR Part 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES21 CFR Part 882 - NEUROLOGICAL DEVICES21 CFR Part 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES21 CFR Part 886 - OPHTHALMIC DEVICES21 CFR Part 888 - ORTHOPEDIC DEVICES21 CFR Part 890 - PHYSICAL MEDICINE DEVICES21 CFR Part 892 - RADIOLOGY DEVICES21 CFR Part 89721 CFR Part 1002 - RECORDS AND REPORTS21 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