21 U.S.C. 360c: Classification of devices intended for human use

2022

• Pub. L. 117–286, §4(a)(155)(A), substituted "Section 1013 of title 5" for "Section 14 of the Federal Advisory Committee Act" in concluding provisions. Law text · (b)
• Pub. L. 117–286, §4(a)(155)(B), substituted "chapter 10 of title 5." for "Federal Advisory Committee Act." Law text · (b)
• Pub. L. 117–328 added subsec. (k). (Consolidated Appropriations Act, 2023) Law text · (k)

2017

• Pub. L. 115–52, §901(h), substituted "medical devices that may be specifically the subject of a review by a classification panel" for "medical device submissions". (FDA Reauthorization Act of 2017) Law text · (b)
• Pub. L. 115–52, §707(b), struck out par. (9) which read as follows: "The Secretary shall classify an accessory under this section based on the intended use of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used." (FDA Reauthorization Act of 2017) Law text · (b)
• Pub. L. 115–52, §707(a), added par. (6). (FDA Reauthorization Act of 2017) Law text · (f)

2016

• Pub. L. 114–255, §3055(a), designated existing provisions as subpar. (A) and added subpars. (B) to (D). (21st Century Cures Act) Law text · (b)
• Pub. L. 114–255, §3055(b)(1), inserted before period at end ", including, subject to the discretion of the panel chairperson, by designating a representative who will be provided a time during the panel meeting to address the panel for the purpose of correcting misstatements… (21st Century Cures Act) Law text · (b)
• Pub. L. 114–255, §3055(b)(2), added subpar. (B) and struck out former subpar. (B) which read as follows: "Any meetings of a classification panel shall provide adequate time for initial presentations and for response to any differing views by persons whose devices are specifically… (21st Century Cures Act) Law text · (b)
• Pub. L. 114–255, §3060(c), added par. (9). (21st Century Cures Act) Law text · (b)
• Pub. L. 114–255, §3101(a)(2)(I)(i), struck out "within 30 days" after "may request,". (21st Century Cures Act) Law text · (f)
• Pub. L. 114–255, §3101(a)(2)(I)(ii), substituted "low to moderate" for "low-moderate". (21st Century Cures Act) Law text · (f)
• Pub. L. 114–255, §3058(a), added subsec. (j). (21st Century Cures Act) Law text · (j)

2012

• Pub. L. 112–144, §602(a), added cls. (iii) and (iv) and redesignated former cl. (iii) as (v). (Food and Drug Administration Safety and Innovation Act) Law text · (a), (b), (c), (d), (e), (f), (g), (h), (i), (j), (k), (l), (m), (n), (o), (p), (q), (r), (s), (t), (u), (v)
• Pub. L. 112–144, §608(a)(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "Based on new information respecting a device, the Secretary may, upon his own initiative or upon petition of an interested person, by regulation (A) change such device's classific… (Food and Drug Administration Safety and Innovation Act) Law text · (e)
• Pub. L. 112–144, §608(a)(2)(A), substituted "an order issued" for "regulation promulgated" in introductory provisions. (Food and Drug Administration Safety and Innovation Act) Law text · (e)
• Pub. L. 112–144, §607(b), added subpar. (C). (Food and Drug Administration Safety and Innovation Act) Law text · (f)
• Pub. L. 112–144, §607(a)(1)–(3), designated existing provisions as cl. (i), struck out "under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1) of this section. The person may, in the request, recommend to the Secretary a classification for the device. … (Food and Drug Administration Safety and Innovation Act) Law text · (f)
• Pub. L. 112–144, §607(a)(4), substituted "The Secretary" for "Not later than 60 days after the date of the submission of the request under subparagraph (A), the Secretary". (Food and Drug Administration Safety and Innovation Act) Law text · (f)
• Pub. L. 112–144, §602(b), designated existing provisions as cl. (i) and added cls. (ii) and (iii). (Food and Drug Administration Safety and Innovation Act) Law text · (i)

2002

• Pub. L. 107–250 struck out cl. (iv) which read as follows: "This subparagraph has no legal effect after the expiration of the five-year period beginning on November 21, 1997." (Medical Device User Fee and Modernization Act of 2002) Law text · (i)

1997

• Pub. L. 105–115, §217, substituted "1 or more clinical investigations" for "clinical investigations". (Food and Drug Administration Modernization Act of 1997) Law text · (a)
• Pub. L. 105–115, §205(a), added subpars. (C) and (D). (Food and Drug Administration Modernization Act of 1997) Law text · (a), (D)
• Pub. L. 105–115, §208, added pars. (5) to (8). (Food and Drug Administration Modernization Act of 1997) Law text · (b)
• Pub. L. 105–115, §207(1)(B), substituted "paragraph (2) or (3)" for "paragraph (2)" in closing provisions. (Food and Drug Administration Modernization Act of 1997) Law text · (f)
• Pub. L. 105–115, §207(1)(A), substituted "paragraph (3)" for "paragraph (2)". (Food and Drug Administration Modernization Act of 1997) Law text · (f)
• Pub. L. 105–115, §207(2), (3), added par. (2) and redesignated former pars. (2) and (3) as (3) and (4), respectively. (Food and Drug Administration Modernization Act of 1997) Law text · (f)
• Pub. L. 105–115, §206(b), added par. (5). (Food and Drug Administration Modernization Act of 1997) Law text · (f)
• Pub. L. 105–115, §206(c)(1), substituted "appropriate clinical or scientific data" for "clinical data", inserted "or a person accredited under section 360m of this title" after "Secretary", and substituted "effectiveness" for "efficacy". (Food and Drug Administration Modernization Act of 1997) Law text · (i)
• Pub. L. 105–115, §205(b), added subpars. (C) to (E). (Food and Drug Administration Modernization Act of 1997) Law text · (i)
• Pub. L. 105–115, §206(c)(2), added subpar. (F). (Food and Drug Administration Modernization Act of 1997) Law text · (i)

1993

• Pub. L. 103–80 substituted "5703" for "5703(b)". · (b)

1992

• Pub. L. 102–300 redesignated clauses (i) to (iii) as subpars. (A) to (C), respectively, and substituted "the section 360(k) report" for "the 360(k) report" in closing provisions. · (f)

1990

• Pub. L. 101–629, §5(a)(1), substituted "or to establish special controls" for "or to establish a performance standard". · (a)
• Pub. L. 101–629, §5(a)(2), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "Class II, Performance Standards.—A device which cannot be classified as a class I device because the controls authorized by or under sections 351, 352, 360, 360f, 360h, 360… · (a)
• Pub. L. 101–629, §5(a)(3), amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: "it (I) cannot be classified as a class I device because insufficient information exists to determine that the controls authorized by or under sections 351, 352, 360, 360f, 360h,… · (a)
• Pub. L. 101–629, §5(b), designated existing provisions as par. (1), redesignated cls. (1) and (2) as (A) and (B), respectively, and added par. (2). · (e)
• Pub. L. 101–629, §5(c)(3), inserted "and reclassification" before "of" in heading. · (f)
• Pub. L. 101–629, §5(c)(1), 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". · (f)
• Pub. L. 101–629, §18(a), substituted "the Secretary may for good cause shown" for "the Secretary shall". · (f)
• Pub. L. 101–629, §4(a), added par. (3). · (f)
• Pub. L. 101–629, §12(a), added subsec. (i). · (i)