Source: https://www.law.cornell.edu/uscode/text/21/360d?quicktabs_8=4
Timestamp: 2015-12-01 21:58:49
Document Index: 738123720

Matched Legal Cases: ['§ 360', '§\u202f360', '§\u202f514', '§\u202f2', '§\u202f304', '§\u202f6', '§\u202f6', '§\u202f4', '§\u202f204', '§\u202f608', '§\u202f204', '§\u202f204', '§\u202f204', '§\u202f204', '§\u202f204', '§\u202f18', '§\u202f6', '§\u202f18', '§\u202f6', '§\u202f6', '§\u202f6', '§\u202f6', '§\u202f6', '§\u202f18', '§\u202f6', '§\u202f4', '§\u202f18', '§\u202f6', '§\u202f4', '§\u202f6', '§\u202f6', 'art 3', 'art 4', 'art 5', 'art 7', '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 310', 'art 570', 'art 571', 'art 610', 'art 660', 'art 809', 'art 812', 'art 814', 'art 820', 'art 830', 'art 860', 'art 861']

21 U.S. Code § 360d - Performance standards | US Law | LII / Legal Information Institute
§ 360d.
The special controls required by section 360c(a)(1)(B) of this title shall include performance standards for a class II device if the Secretary determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device. A class III device may also be considered a class II device for purposes of establishing a standard for the device under subsection (b) of this section if the device has been reclassified as a class II device under an administrative order under section 360c(e) of this title (or a regulation promulgated under such section prior to July 9, 2012) but such order (or regulation) provides that the reclassification is not to take effect until the effective date of such a standard for the device.
(2) A performance standard established under subsection (b) of this section for a device—
(B) shall, where necessary to provide reasonable assurance of its safe and effective performance, include—
a provision requiring that the sale and distribution of the device be restricted but only to the extent that the sale and distribution of a device may be restricted under a regulation under section 360j(e) of this title; and
(4) In carrying out his duties under this subsection and subsection (b) of this section, the Secretary shall, to the maximum extent practicable—
(B) A notice of proposed rulemaking for the establishment or amendment of a performance standard for a device shall—
invite interested persons to submit to the Secretary, within 30 days of the publication of the notice, requests for changes in the classification of the device pursuant to section 360c(e) of this title based on new information relevant to the classification, and
If, after publication of a notice in accordance with paragraph (1), the Secretary receives a request for a change in the classification of the device, the Secretary shall, within 60 days of the publication of the notice, after consultation with the appropriate panel under section 360c of this title, either deny the request or give notice of an intent to initiate such change under section 360c(e) of this title.
After the expiration of the period for comment on a notice of proposed rulemaking published under paragraph (1) respecting a performance standard and after consideration of such comments and any report from an advisory committee under paragraph (5), the Secretary shall (i) promulgate a regulation establishing a performance standard and publish in the Federal Register findings on the matters referred to in paragraph (1), or (ii) publish a notice terminating the proceeding for the development of the standard together with the reasons for such termination. If a notice of termination is published, the Secretary shall (unless such notice is issued because the device is a banned device under section 360f of this title) initiate a proceeding under section 360c(e) of this title to reclassify the device subject to the proceeding terminated by such notice.
A regulation establishing a performance standard shall set forth the date or dates upon which the standard shall take effect, but no such regulation may take effect before one year after the date of its publication unless (i) the Secretary determines that an earlier effective date is necessary for the protection of the public health and safety, or (ii) such standard has been established for a device which, effective upon the effective date of the standard, has been reclassified from class III to class II. Such date or dates shall be established so as to minimize, consistent with the public health and safety, economic loss to, and disruption or dislocation of, domestic and international trade.
(A) Subject to subparagraph (B), the Secretary shall accept a declaration of conformity that a device is in conformity with a standard recognized under paragraph (1) unless the Secretary finds—
(June 25, 1938, ch. 675, § 514, as added Pub. L. 94–295, § 2, May 28, 1976, 90 Stat. 546; amended Pub. L. 94–460, title III, § 304, Oct. 8, 1976, 90 Stat. 1960; Pub. L. 101–629, §§ 6(a), (b)(1), 18(b), Nov. 28, 1990, 104 Stat. 4519, 4528; Pub. L. 102–300, § 6(g), June 16, 1992, 106 Stat. 241; Pub. L. 103–80, § 4(a)(1), Aug. 13, 1993, 107 Stat. 779; Pub. L. 105–115, title II, § 204(a), (d), Nov. 21, 1997, 111 Stat. 2335, 2336; Pub. L. 112–144, title VI, § 608(a)(2)(B), July 9, 2012, 126 Stat. 1056.)
2012—Subsec. (a)(1). Pub. L. 112–144 substituted “under an administrative order under section 360c(e) of this title (or a regulation promulgated under such section prior to July 9, 2012) but such order (or regulation)” for “under a regulation under section 360c(e) of this title but such regulation”.
1997—Subsec. (a)(1). Pub. L. 105–115, § 204(d)(1), substituted “under subsection (b) of this section” for “under this section”.
Subsec. (a)(2). Pub. L. 105–115, § 204(d)(2), substituted “under subsection (b) of this section” for “under this section” in introductory provisions.
Subsec. (a)(3). Pub. L. 105–115, § 204(d)(3), substituted “under subsection (b) of this section” for “under this section”.
Subsec. (a)(4). Pub. L. 105–115, § 204(d)(4), substituted “this subsection and subsection (b) of this section” for “this section” in introductory provisions.
Subsec. (c). Pub. L. 105–115, § 204(a), added subsec. (c).
1993—Subsec. (b)(4)(B), (5)(A)(ii). Pub. L. 103–80 amended directory language of Pub. L. 101–619, § 18(b), identical to amendment by Pub. L. 102–300, § 6(g)(1). See 1992 and 1990 Amendment notes below.
1992—Subsec. (b)(4)(B), (5)(A)(ii). Pub. L. 102–300 made technical corrections to directory language of Pub. L. 101–629, § 18(b)(1), (2). See 1990 Amendment note below.
1990—Subsec. (a)(1). Pub. L. 101–629, § 6(a)(1), substituted “The special controls required by section 360c(a)(1)(B) of this title shall include performance standards for a class II device if the Secretary determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device.” for “The Secretary may by regulation, promulgated in accordance with this section, establish a performance standard for a class II device.”
Subsec. (b). Pub. L. 101–629, § 6(a)(2), (3), redesignated subsec. (g) as (b) and struck out former subsec. (b) which read as follows:
“(2) If, after publication of a notice pursuant to paragraph (1) the Secretary receives a request for a change in the device’s classification, he shall, within sixty days of the publication of such notice and after consultation with the appropriate panel under section 360c of this title, by order published in the Federal Register, either deny the request for change in classification or give notice of his intent to initiate such a change under section 360c(e) of this title.”
Subsec. (b)(1), (2). Pub. L. 101–629, § 6(a)(4), amended pars. (1) and (2) generally. Prior to amendment, pars. (1) and (2) read as follows:
“(B) If the Secretary issues under subparagraph (A)(ii) a notice of termination of a proceeding to establish a performance standard for a device, he shall (unless such notice is issued because the device is a banned device under section 360f of this title) initiate a proceeding under section 360c(e) of this title to reclassify the device subject to the proceeding terminated by such notice.
Subsec. (b)(3)(A)(i). Pub. L. 101–629, § 6(b)(1)(A), substituted “paragraph (1)” for “paragraph (2)”.
Subsec. (b)(4)(A). Pub. L. 101–629, § 6(b)(1)(B), substituted “paragraphs (1), (2), and (3)(B)” for “paragraphs (2) and (3)(B)”.
Subsec. (b)(4)(B). Pub. L. 101–629, § 18(b)(1), as amended by Pub. L. 102–300, § 6(g)(1), (2), and Pub. L. 103–80, § 4(a)(1), struck out “, after affording all interested persons an opportunity for an informal hearing,” after “if he determines”.
Subsec. (b)(5)(A)(ii). Pub. L. 101–629, § 18(b)(2), as amended by Pub. L. 102–300, § 6(g)(1), (3), and Pub. L. 103–80, § 4(a)(1), substituted “which demonstrates good cause for referral and which is made before the expiration of the period for submission of comments on such proposed regulation refer such proposed regulation,” for “unless the Secretary finds the request to be without good cause or the request is made after the expiration of the period for submission of comments on such proposed regulation refer such proposed regulation,”.
Subsecs. (c) to (f). Pub. L. 101–629, § 6(a)(2), struck out subsec. (c) relating to invitations for standards, subsec. (d) relating to acceptance of certain existing standards, subsec. (e) relating to acceptance of offers to develop standards, and subsec. (f) relating to development of standards by the Secretary after publication of notice inviting submissions or offers of standards.
Subsec. (g). Pub. L. 101–629, § 6(a)(3), redesignated subsec. (g) as (b).
1976—Subsec. (a). Pub. L. 94–460 redesignated pars. (4) and (5) as (3) and (4), respectively. Section as originally enacted contained no par. (3).
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 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 310 - NEW DRUGS21 CFR Part 570 - FOOD ADDITIVES21 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 812 - INVESTIGATIONAL DEVICE EXEMPTIONS21 CFR Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES21 CFR Part 820 - QUALITY SYSTEM REGULATION21 CFR Part 830 - UNIQUE DEVICE IDENTIFICATION21 CFR Part 860 - MEDICAL DEVICE CLASSIFICATION PROCEDURES21 CFR Part 861 - PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT