21 U.S.C. 360: Registration of producers of drugs or devices

2022

• Pub. L. 117–328, §3613(a), added subpar. (F) and redesignated former subpar. (F) as (G). (Consolidated Appropriations Act, 2023) Law text · (h), (G)
• Pub. L. 117–328, §3616(c)(1)(A), substituted "Not" for "Beginning in 2014, not" in introductory provisions. (Consolidated Appropriations Act, 2023) Law text · (h)
• Pub. L. 117–328, §3616(c)(1)(B), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: (Consolidated Appropriations Act, 2023) Law text · (h)
• Pub. L. 117–328, §3616(c)(1)(C)–(E), added subpar. (D). (Consolidated Appropriations Act, 2023) Law text · (h)
• Pub. L. 117–328, §3616(c)(2), added par. (7). (Consolidated Appropriations Act, 2023) Law text · (h)
• Pub. L. 117–328, §2511(a), added par. (5). (Consolidated Appropriations Act, 2023) Law text · (i)
• Pub. L. 117–328, §2515(a)(3), made technical amendment to directory language of Pub. L. 116–136, §3112(e). See 2020 Amendment note below. (Consolidated Appropriations Act, 2023) Law text · (j)
• Pub. L. 117–328, §3308(b)(1), inserted ", or with respect to a change that is consistent with a predetermined change control plan cleared under section 360e–4 of this title" after "section 360c of this title". (Consolidated Appropriations Act, 2023) Law text · (l)

2020

• Pub. L. 116–136, §3112(e), as amended by Pub. L. 117–328, §2515(a)(3), added par. (3) and redesignated former pars. (3) and (4) as (4) and (5), respectively. (Coronavirus Aid, Relief, and Economic Security Act" or the "CARES Act) Law text · (j)

2017

• Pub. L. 115–52, §701(a)(1), added par. (2) and struck out former par. (2). Prior to amendment, text read as follows: "Every establishment described in paragraph (1), in any State, that is engaged in the manufacture, propagation, compounding, or processing of a device or devices clas… (FDA Reauthorization Act of 2017) Law text · (h)
• Pub. L. 115–52, §701(a)(2)(A), substituted "paragraph (2) or (3)" for "paragraph (3)" in introductory provisions. (FDA Reauthorization Act of 2017) Law text · (h)
• Pub. L. 115–52, §701(a)(2)(B), inserted "or device" after "drug". (FDA Reauthorization Act of 2017) Law text · (h)
• Pub. L. 115–52, §901(e), substituted "May 1" for "February 1" in introductory provisions. (FDA Reauthorization Act of 2017) Law text · (h)

2016

• Pub. L. 114–255, §3101(a)(2)(H)(i), substituted "establishing a risk-based schedule" for "establishing the risk-based scheduled" in introductory provisions. (21st Century Cures Act) Law text · (h)
• Pub. L. 114–255, §3101(a)(2)(H)(ii)(I), substituted "calendar" for "fiscal" in cls. (i) and (ii). (21st Century Cures Act) Law text · (h)
• Pub. L. 114–255, §3101(a)(2)(H)(ii)(II), substituted "an active ingredient of a drug or a finished drug product" for "an active ingredient of a drug, a finished drug product, or an excipient of a drug". (21st Century Cures Act) Law text · (h)
• Pub. L. 114–255, §3054(a), designated existing provisions as par. (1) and added par. (2). (21st Century Cures Act) Law text · (l)
• Pub. L. 114–255, §3054(b)(1), added par. (1) and struck out former par. (1) which read as follows: "Not later than 60 days after November 21, 1997, the Secretary shall publish in the Federal Register a list of each type of class II device that does not require a report under subsect… (21st Century Cures Act) Law text · (m)
• Pub. L. 114–255, §3054(b)(2)(B), substituted "60-calendar-day period" for "30-day period". (21st Century Cures Act) Law text · (m)
• Pub. L. 114–255, §3054(b)(2)(A), which directed the substitution of "1 calendar day after the date of publication of the final list under paragraph (1)(B)," for "1 day after the date of publication of a list under this subsection,", was executed by making the substitution for "1 day after the date … (21st Century Cures Act) Law text · (m)
• Pub. L. 114–255, §3054(b)(2)(C), added par. (3). (21st Century Cures Act) Law text · (m)
• Pub. L. 114–255, §3059(a), added subsec. (q). (21st Century Cures Act) Law text · (q)

2012

• Pub. L. 112–144, §701(1)(A), which directed amendment of par. (1) by "striking 'On or before' and all that follows through the period at the end and inserting the following: 'During the period beginning on October 1 and ending on December 31 of each year, every person who owns or op… (Food and Drug Administration Safety and Innovation Act) Law text · (b)
• Pub. L. 112–144, §701(1)(B), added par. (3). (Food and Drug Administration Safety and Innovation Act) Law text · (b)
• Pub. L. 112–144, §701(2), substituted "with the Secretary—" and pars. (1) and (2) for "with the Secretary his name, place of business, and such establishment". (Food and Drug Administration Safety and Innovation Act) Law text · (c)
• Pub. L. 112–144, §705, amended subsec. (h) generally. Prior to amendment, text read as follows: "Every establishment in any State registered with the Secretary pursuant to this section shall be subject to inspection pursuant to section 374 of this title and every such establishment eng… (Food and Drug Administration Safety and Innovation Act) Law text · (h)
• Pub. L. 112–144, §702(b)(1)(A), amended introductory provisions generally. Prior to amendment, text read as follows: "Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device that is imported or… (Food and Drug Administration Safety and Innovation Act) Law text · (i)
• Pub. L. 112–144, §702(b)(1)(B), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "upon first engaging in any such activity, immediately register with the Secretary the name and place of business of the establishment, the name of the United States ag… (Food and Drug Administration Safety and Innovation Act) Law text · (i)
• Pub. L. 112–144, §702(b)(1)(C), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "each establishment subject to the requirements of subparagraph (A) shall thereafter— (Food and Drug Administration Safety and Innovation Act) Law text · (i)
• Pub. L. 112–144, §702(b)(2), added par. (4). (Food and Drug Administration Safety and Innovation Act) Law text · (i)
• Pub. L. 112–144, §703(1), added subpar. (E). (Food and Drug Administration Safety and Innovation Act) Law text · (j)
• Pub. L. 112–144, §703(2), added par. (4). (Food and Drug Administration Safety and Innovation Act) Law text · (j)
• Pub. L. 112–144, §604, designated existing provisions as par. (1) and added par. (2). (Food and Drug Administration Safety and Innovation Act) Law text · (n)
• Pub. L. 112–144, §704, inserted subsec. heading, designated existing provisions as par. (1) and inserted par. heading, and added pars. (2) and (3). (Food and Drug Administration Safety and Innovation Act) Law text · (p)

2007

• Pub. L. 110–85, §222(a), designated existing provisions as par. (1), struck out "or a device or devices" after "drug or drugs", and added par. (2). (Food and Drug Administration Amendments Act of 2007) Law text · (b)
• Pub. L. 110–85, §222(b), inserted text of par. (1) and struck out former text of par. (1) which related to registration requirement for foreign establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device to be imported or offer… (Food and Drug Administration Amendments Act of 2007) Law text · (i)
• Pub. L. 110–85, §223, in introductory provisions, substituted "Each person who registers with the Secretary under this section shall report to the Secretary, with regard to drugs once during the month of June of each year and once during the month of December of each year, and with … (Food and Drug Administration Amendments Act of 2007) Law text · (j)
• Pub. L. 110–85, §801(b)(3)(C), inserted concluding provisions. (Food and Drug Administration Amendments Act of 2007) Law text · (k)
• Pub. L. 110–85, §224, amended subsec. (p) generally. Prior to amendment, subsec. (p) read as follows: "Registrations under subsections (b), (c), (d), and (i) of this section (including the submission of updated information) shall be submitted to the Secretary by electronic means, upon … (Food and Drug Administration Amendments Act of 2007) Law text · (p)

2004

• Pub. L. 108–214, §2(c)(2)(A), (B)(i), substituted "or adulterated" for ", adulterated". Law text · (o), (2)
• Pub. L. 108–214, §2(c)(2)(B)(ii), substituted "semi-critical" for "semicritical". Law text · (o)

2002

• Pub. L. 107–250, §201(e), inserted ", or by persons accredited to conduct inspections under section 374(g) of this title," after "duly designated by the Secretary". (Medical Device User Fee and Modernization Act of 2002) Law text · (h)
• Pub. L. 107–188, §321(a)(1), substituted "On or before December 31 of each year, any establishment" for "Any establishment" and "shall, through electronic means in accordance with the criteria of the Secretary, register with the Secretary the name and place of business of the establ… (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (i)
• Pub. L. 107–188, §321(a)(2), substituted "subsection (b), (c), (d), or (i)" for "subsection (b), (c), or (d)" in first sentence. (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (j)
• Pub. L. 107–250, §211, inserted at end "The Secretary shall publish such list on the Internet site of the Food and Drug Administration. The list so published shall be updated not later than 30 days after each revision of the list by the Secretary." (Medical Device User Fee and Modernization Act of 2002) Law text · (m)
• Pub. L. 107–250, §302(b), added subsec. (o). (Medical Device User Fee and Modernization Act of 2002) Law text · (o)
• Pub. L. 107–250, §207, added subsec. (p). (Medical Device User Fee and Modernization Act of 2002) Law text · (p)

1997

• Pub. L. 105–115, §213(b)(3), inserted at end "In this subsection, the term 'wholesale distributor' means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale o… (Food and Drug Administration Modernization Act of 1997) Law text · (g)
• Pub. L. 105–115, §213(b)(1), (2), added par. (4) and redesignated former par. (4) as (5). (Food and Drug Administration Modernization Act of 1997) Law text · (g), (5)
• Pub. L. 105–115, §417, amended subsec. (i) generally. Prior to amendment, subsec. (i) read as follows: "Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs, or a device or devices, shall be per… (Food and Drug Administration Modernization Act of 1997) Law text · (i)
• Pub. L. 105–115, §125(a)(2)(C), struck out ", 356, 357," before "or 360b of this title". (Food and Drug Administration Modernization Act of 1997) Law text · (j), (D)
• Pub. L. 105–115, §206(a)(1), inserted "or person who is accredited under section 360m(a) of this title" after "report to the Secretary". (Food and Drug Administration Modernization Act of 1997) Law text · (k)
• Pub. L. 105–115, §206(a)(2), added subsecs. (l) and (m). (Food and Drug Administration Modernization Act of 1997) Law text · (l), (m)
• Pub. L. 105–115, §209(a), added subsec. (n). (Food and Drug Administration Modernization Act of 1997) Law text · (n)

1976

• Pub. L. 94–295, §4(a)(2), substituted "drug package or device package" for "drug package", "distribution of the drug or device" for "distribution of the drug", and "ultimate consumer or user" for "ultimate consumer". · (a)
• Pub. L. 94–295, §4(a)(3), inserted "or a device or devices" after "drug or drugs". · (b), (c), (d)
• Pub. L. 94–295, §4(a)(4), authorized the Secretary to prescribe by regulation a uniform system for the identification of devices intended for human use and authorized him, in addition, to require that persons who are required to list devices pursuant to subsec. (j) also list such devic… · (e)
• Pub. L. 94–295, §4(a)(5), substituted "drugs or devices" for "drugs". · (g)
• Pub. L. 94–295, §4(a)(6), inserted reference to establishments engaged in the manufacture, propagation, compounding, or processing of a drug or drugs or of a device or devices classified in class II or III. · (h)
• Pub. L. 94–295, §4(a)(7), inserted reference to devices and inserted requirement that regulations require establishments to provide the information required by subsection (j) of this section in the case of a device or devices. · (i)
• Pub. L. 94–295, §4(a)(8)(A), in introductory provisions substituted "a list of all drugs and a list of all devices and a brief statement of the basis for believing that each device included in the list is a device rather than a drug (with each drug and device in each list listed by … · (j)
• Pub. L. 94–295, §4(a)(8)(B), substituted "the applicable list" for "such list", inserted "or a device intended for human use contained in the applicable list with respect to which a performance standard has been established under section 360d of this title or which is subject to … · (j)
• Pub. L. 94–295, §4(a)(8)(C), in introductory provisions substituted "drug or device contained in an applicable list" for "drug contained in such list". · (j)
• Pub. L. 94–295, §4(a)(8)(D), substituted "which drug is subject to section 353(b)(1) of this title, or which device is a restricted device, a copy of all labeling for such drug or device, a representative sampling of advertisements for such drug or device, and, upon request ma… · (j)
• Pub. L. 94–295, §4(a)(8)(E), substituted "which drug is not subject to section 353(b)(1) of this title or which device is not a restricted device, the label and package insert for such drug or device and a representative sampling of any other labeling for such drug or device"… · (j)
• Pub. L. 94–295, §4(a)(8)(F), substituted "an applicable list" for "such list". · (j)
• Pub. L. 94–295, §4(a)(8)(G), substituted "a list" for "the list", inserted "or the particular device contained in such list is not subject to a performance standard established under section 360d of this title or to section 360e of this title or is not a restricted device" after … · (j)
• Pub. L. 94–295, §4(a)(8)(H), substituted "drug or device" for "drug" in subpars. (A), (B), and (C), and substituted "(each by established name" for "(by established name" in subpar. (C). · (j)
• Pub. L. 94–295, §4(a)(9), added subsec. (k). · (k)

1972

• Pub. L. 92–387, §4(a), inserted provision that the Secretary may assign a listing number to each drug or class of drugs listed under subsec. (j). · (e)
• Pub. L. 92–387, §4(b), inserted exception that the list submitted under subsec. (j)(3) and information submitted under subsec. (j)(1), (2) shall be exempt from inspection unless the Secretary determines otherwise. · (f)
• Pub. L. 92–387, §4(c), inserted provision that the regulations shall require such establishment to provide the information required by subsec. (j). · (i)
• Pub. L. 92–387, §3, added subsec. (j). · (j)

1970

• Pub. L. 91–513 struck out provisions defining the wholesaling, jobbing, or distributing of depressant or stimulant drugs. · (a)
• Pub. L. 91–513 struck out provisions covering establishments engaged in the wholesaling, jobbing, or distributing of depressant or stimulant drugs and the inclusion of the fact of such activity in the annual registration. · (b)
• Pub. L. 91–513 struck out provisions covering new registrations of persons first engaging in the wholesaling, jobbing, or distributing of depressant or stimulant drugs and the inclusion of the fact of such activity in the registration. · (c)
• Pub. L. 91–513 struck out number designation "(1)" preceding first sentence, struck out portion of such redesignated provisions covering the wholesaling, jobbing, or distributing of depressant or stimulant drugs, and struck out par. (2) covering the filing of supplemental registration … · (d)

1965

• Pub. L. 89–74, §4(e), included certain wholesalers in section catchline.
• Pub. L. 89–74, §4(a), added par. (2) and redesignated former par. (2) as (3). · (a), (3)
• Pub. L. 89–74, §4(b), (c), inserted "or in the wholesaling, jobbing, or distributing of any depressant or stimulant drug" after "drug or drugs" and inserted requirement that establishment indicate activity in depressant or stimulant drugs at time of registration. · (b), (c)
• Pub. L. 89–74 §4(d), designated existing provisions as par. (1), inserted "or the wholesaling, jobbing, or distributing of any depressant or stimulant drug" and the requirement that the additional establishment indicate activity in depressant or stimulant drugs at time of registration,… · (d)