Source: https://www.law.cornell.edu/uscode/text/21/360
Timestamp: 2017-04-30 20:43:37
Document Index: 112191941

Matched Legal Cases: ['§\u202f510', '§\u202f302', '§\u202f4', '§\u202f701', '§\u202f3', '§\u202f4', '§\u202f125', '§\u202f206', '§\u202f417', '§\u202f321', '§\u202f201', '§\u202f302', '§\u202f2', '§\u202f222', '§\u202f801', '§\u202f604', '§\u202f701', '§\u202f3054', '§\u202f3101', '§\u202f3101', '§\u202f3101', '§\u202f3054', '§\u202f3054', '§\u202f3054', '§\u202f3054', '§\u202f3054', '§\u202f3059', '§\u202f701', '§\u202f701', '§\u202f701', '§\u202f705', '§\u202f702', '§\u202f702', '§\u202f702', '§\u202f702', '§\u202f703', '§\u202f703', '§\u202f604', '§\u202f704', '§\u202f222', '§\u202f222', '§\u202f223', '§\u202f801', '§\u202f224', '§\u202f2', '§\u202f2', '§\u202f201', '§\u202f321', '§\u202f321', '§\u202f211', '§\u202f302', '§\u202f207', '§\u202f213', '§\u202f213', '§\u202f417', '§\u202f125', '§\u202f206', '§\u202f206', '§\u202f209', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f3', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f4', '§\u202f5', '§\u202f3059', '§\u202f2', '§\u202f301', '§\u202f303', '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 71', 'art 99', 'art 201', 'art 203', 'art 206', 'art 207', 'art 208', 'art 225', 'art 330', 'art 331', 'art 332', 'art 333', 'art 335', 'art 336', 'art 338', 'art 340', 'art 341', 'art 343', 'art 344', 'art 346', 'art 347', 'art 348', 'art 349', 'art 350', 'art 352', 'art 355', 'art 357', 'art 358', 'art 571', 'art 600', 'art 601', 'art 606', 'art 606', 'art 607', 'art 610', 'art 630', 'art 640', 'art 660', 'art 680', 'art 803', 'art 806', 'art 807', 'art 809', 'art 812', 'art 814', 'art 820', 'art 821', 'art 830', 'art 862', 'art 864', 'art 866', 'art 868', 'art 870', 'art 872', 'art 874', '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 1030', 'art 1040', 'art 1050']

(4) Risk factorsIn establishing a risk-based schedule under paragraph (3), the Secretary shall inspect establishments according to the known safety risks of such establishments, which shall be based on the following factors:
(6) Annual report on inspections of establishmentsBeginning in 2014, not later than February 1 of each year, the Secretary shall make available on the Internet Web site of the Food and Drug Administration a report regarding—
the number of domestic and foreign establishments registered pursuant to this section in the previous calendar year; and
the number of such domestic establishments and the number of such foreign establishments that the Secretary inspected in the previous calendar year;
with respect to establishments that manufacture, prepare, propagate, compound, or process an active ingredient of a drug or a finished drug product, the number of each such type of establishment; and
The establishment shall also provide the information required by subsection (j).
The Secretary is authorized to enter into cooperative arrangements with officials of foreign countries to ensure that adequate and effective means are available for purposes of determining, from time to time, whether drugs or devices manufactured, prepared, propagated, compounded, or processed by an establishment described in paragraph (1), if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in section 381(a) of this title.
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 made by the Secretary for good cause, a copy of all advertisements for a particular drug product or device, or
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;
A list of each drug or device introduced by the registrant for commercial distribution which has not been included in any list previously filed by him with the Secretary under this subparagraph or paragraph (1) of this subsection. A list under this subparagraph shall list a drug or device by its established name (as defined in section 352(e) of this title), and by any proprietary name it may have and shall be accompanied by the other information required by paragraph (1).
If since the date the registrant last made a report under this paragraph (or if he has not made a report under this paragraph, since February 1, 1973) he has discontinued the manufacture, preparation, propagation, compounding, or processing for commercial distribution of a drug or device included in a list filed by him under subparagraph (A) or paragraph (1); notice of such discontinuance, the date of such discontinuance, and the identity (by established name (as defined in section 352(e) of this title) and by any proprietary name) of such drug or device.
If since the date the registrant reported pursuant to subparagraph (B) a notice of discontinuance he has resumed the manufacture, preparation, propagation, compounding, or processing for commercial distribution of the drug or device with respect to which such notice of discontinuance was reported; notice of such resumption, the date of such resumption, the identity of such drug or device (each by established name (as defined in section 352(e) of this title) and by any proprietary name), and the other information required by paragraph (1), unless the registrant has previously reported such resumption to the Secretary pursuant to this subparagraph.
The Secretary may also require each registrant under this section to submit a list of each drug product which (A) the registrant is manufacturing, preparing, propagating, compounding, or processing for commercial distribution, and (B) contains a particular ingredient. The Secretary may not require the submission of such a list unless he has made a finding that the submission of such a list is necessary to carry out the purposes of this chapter.
(k) Report preceding introduction of devices into interstate commerceEach person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use shall, at least ninety days before making such introduction or delivery, report to the Secretary or person who is accredited under section 360m(a) of this title (in such form and manner as the Secretary shall by regulation prescribe)—
A report under subsection (k) is not required for a device intended for human use that is exempted from the requirements of this subsection under subsection (m) or is within a type that has been classified into class I under section 360c of this title. The exception established in the preceding sentence does not apply to any class I device that is intended for a use which is of substantial importance in preventing impairment of human health, or to any class I device that presents a potential unreasonable risk of illness or injury.
provide for a period of not less than 60 calendar days for public comment beginning on the date of the publication of such notice; and
not later than 210 calendar days after December 13, 2016, publish in the Federal Register a list representing the Secretary’s final determination with respect to the devices contained in the list published under subparagraph (A).
Beginning on the date that is 1 calendar day after the date of publication of the final list under paragraph (1)(B), the Secretary may exempt a class II device from the requirement to submit a report under subsection (k), upon the Secretary’s own initiative or a petition of an interested person, if the Secretary determines that such report is not necessary to assure the safety and effectiveness of the device. The Secretary shall publish in the Federal Register notice of the intent of the Secretary to exempt the device, or of the petition, and provide a 60-calendar-day period for public comment. Within 120 days after the issuance of the notice in the Federal Register, the Secretary shall publish an order in the Federal Register that sets forth the final determination of the Secretary regarding the exemption of the device that was the subject of the notice. If the Secretary fails to respond to a petition within 180 days of receiving it, the petition shall be deemed to be granted.
The Secretary shall review the report required in subsection (k) and make a determination under section 360c(f)(1) of this title not later than 90 days after receiving the report.
(B) The Secretary shall withdraw the Food and Drug Administration draft guidance entitled “Guidance for Industry and FDA Staff—510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device”, dated July 27, 2011, and shall not use this draft guidance as part of, or for the basis of, any premarket review or any compliance or enforcement decisions or actions. The Secretary shall not issue—
The Secretary shall identify such devices or types of devices for which reports under such subsection must, in order to ensure that the device is substantially equivalent to a predicate device, include validation data, the types of which shall be specified by the Secretary, regarding cleaning and sterilization, and functional performance demonstrating that the single-use device will remain substantially equivalent to its predicate device after the maximum number of times the device is reprocessed as intended by the person submitting the premarket notification. Within six months after October 26, 2002, the Secretary shall publish in the Federal Register a list of the types so identified, and shall revise the list as appropriate. Reports under subsection (k) for devices or types of devices within a type included on the list are, upon publication of the list, required to include such validation data.
In the case of each report under subsection (k) that was submitted to the Secretary before the publication of the initial list under subparagraph (A), or any revision thereof, and was for a device or type of device included on such list, the person who submitted the report under subsection (k) shall submit validation data as described in subparagraph (A) to the Secretary not later than nine months after the publication of the list. During such nine-month period, the Secretary may not take any action under this chapter against such device solely on the basis that the validation data for the device have not been submitted to the Secretary. After the submission of the validation data to the Secretary, the Secretary may not determine that the device is misbranded under section 352(o) of this title or adulterated under section 351(f)(1)(B) of this title, or take action against the device under section 331(p) of this title for failure to provide any information required by subsection (k) until (i) the review is terminated by withdrawal of the submission of the report under subsection (k); (ii) the Secretary finds the data to be acceptable and issues a letter; or (iii) the Secretary determines that the device is not substantially equivalent to a predicate device. Upon a determination that a device is not substantially equivalent to a predicate device, or if such submission is withdrawn, the device can no longer be legally marketed.
In the case of a report under subsection (k) for a device identified under subparagraph (A) that is of a type for which the Secretary has not previously received a report under such subsection, the Secretary may, in advance of revising the list under subparagraph (A) to include such type, require that the report include the validation data specified in subparagraph (A).
Section 352(o) of this title applies with respect to the failure of a report under subsection (k) to include validation data required under subparagraph (A).
The Secretary shall identify such devices or types of devices for which such exemptions should be terminated in order to provide a reasonable assurance of the safety and effectiveness of the devices. The Secretary shall publish in the Federal Register a list of the devices or types of devices so identified, and shall revise the list as appropriate. The exemption for each device or type included on the list is terminated upon the publication of the list. For each report under subsection (k) submitted pursuant to this subparagraph the Secretary shall require the validation data described in paragraph (1)(A).
For each device or type of device included on the list under subparagraph (A), a report under subsection (k) shall be submitted to the Secretary not later than 15 months after the publication of the initial list, or a revision of the list, whichever terminates the exemption for the device. During such 15-month period, the Secretary may not take any action under this chapter against such device solely on the basis that such report has not been submitted to the Secretary. After the submission of the report to the Secretary the Secretary may not determine that the device is misbranded under section 352(o) of this title or adulterated under section 351(f)(1)(B) of this title, or take action against the device under section 331(p) of this title for failure to provide any information required by subsection (k) until (i) the review is terminated by withdrawal of the submission; (ii) the Secretary determines by order that the device is substantially equivalent to a predicate device; or (iii) the Secretary determines by order that the device is not substantially equivalent to a predicate device. Upon a determination that a device is not substantially equivalent to a predicate device, the device can no longer be legally marketed.
Section 352(o) of this title applies with respect to the failure to submit a report under subsection (k) that is required pursuant to subparagraph (A), including a failure of the report to include validation data required in such subparagraph.
The termination under subparagraph (A) of an exemption under subsection (l) or (m) for a critical or semi-critical reprocessed single-use device does not terminate the exemption under subsection (l) or (m) for the original device.
(2) Electronic databaseNot later than 2 years after the Secretary specifies a unique facility identifier system under subsections (b) and (i), the Secretary shall maintain an electronic database, which shall not be subject to inspection under subsection (f), populated with the information submitted as described under paragraph (1) that—
uses the unique facility identifier system to link with other relevant databases within the Food and Drug Administration, including the database for submission of information under section 381(r) of this title.
(1) In generalNot later than 180 days after December 13, 2016, the Secretary shall identify and publish a list of reusable device types for which reports under subsection (k) are required to include—
instructions for use, which have been validated in a manner specified by the Secretary; and
validation data, the types of which shall be specified by the Secretary;
The Secretary shall revise the list under paragraph (2),[3] as the Secretary determines appropriate, with notice in the Federal Register.
(June 25, 1938, ch. 675, § 510, as added Pub. L. 87–781, title III, § 302, Oct. 10, 1962, 76 Stat. 794; amended Pub. L. 89–74, § 4, July 15, 1965, 79 Stat. 231; Pub. L. 91–513, title II, § 701(e), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 92–387, §§ 3, 4(a)–(c), Aug. 16, 1972, 86 Stat. 560–562; Pub. L. 94–295, § 4(a), May 28, 1976, 90 Stat. 579; Pub. L. 105–115, title I, § 125(a)(2)(C), title II, §§ 206(a), 209(a), 213(b), title IV, § 417, Nov. 21, 1997, 111 Stat. 2325, 2338, 2341, 2347, 2379; Pub. L. 107–188, title III, § 321(a), June 12, 2002, 116 Stat. 675; Pub. L. 107–250, title II, §§ 201(e), 207, 211, title III, § 302(b), Oct. 26, 2002, 116 Stat. 1609, 1613, 1614, 1616; Pub. L. 108–214, § 2(c)(2), Apr. 1, 2004, 118 Stat. 576; Pub. L. 110–85, title II, §§ 222–224, title VIII, § 801(b)(3)(C), Sept. 27, 2007, 121 Stat. 853, 921; Pub. L. 112–144, title VI, § 604, title VII, §§ 701, 702(b)–705, July 9, 2012, 126 Stat. 1052, 1064–1066; Pub. L. 114–255, div. A, title III, §§ 3054, 3059(a), 3101(a)(2)(H), Dec. 13, 2016, 130 Stat. 1126, 1130, 1154.)
[1]  So in original.[3]  So in original. Probably should be “paragraph (1),”.
2016—Subsec. (h)(4). Pub. L. 114–255, § 3101(a)(2)(H)(i), substituted “establishing a risk-based schedule” for “establishing the risk-based scheduled” in introductory provisions.
Subsec. (h)(6)(A). Pub. L. 114–255, § 3101(a)(2)(H)(ii)(I), substituted “calendar” for “fiscal” in cls. (i) and (ii).
Subsec. (h)(6)(B). 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”.
Subsec. (l). Pub. L. 114–255, § 3054(a), designated existing provisions as par. (1) and added par. (2).
Subsec. (m)(1). 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 subsection (k) to provide reasonable assurance of safety and effectiveness. Each type of class II device identified by the Secretary as not requiring the report shall be exempt from the requirement to provide a report under subsection (k) as of the date of the publication of the list in the Federal Register. 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.”
Subsec. (m)(2). Pub. L. 114–255, § 3054(b)(2)(B), substituted “60-calendar-day period” for “30-day period”.
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 of the publication of a list under this subsection,” to reflect the probable intent of Congress.
Subsec. (m)(3). Pub. L. 114–255, § 3054(b)(2)(C), added par. (3).
Subsec. (q). Pub. L. 114–255, § 3059(a), added subsec. (q).
2012—Subsec. (b)(1). 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 operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary the name of such person, places of business of such person, all such establishments, the unique facility identifier of each such establishment, and a point of contact e-mail address.; and”, was executed as if an end quotation mark for the inserted material followed “address.”, to reflect the probable intent of Congress. Prior to amendment, stricken text read as follows: “On or before December 31 of each year every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary his name, places of business, and all such establishments.”
Subsec. (b)(3). Pub. L. 112–144, § 701(1)(B), added par. (3).
Subsec. (c). 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”.
Subsec. (h). 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 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 shall be so inspected by one or more officers or employees duly designated by the Secretary, or by persons accredited to conduct inspections under section 374(g) of this title, at least once in the two-year period beginning with the date of registration of such establishment pursuant to this section and at least once in every successive two-year period thereafter.”
Subsec. (i)(1). 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 offered for import into the United States shall, through electronic means in accordance with the criteria of the Secretary—”.
Subsec. (i)(1)(A). 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 agent for the establishment, the name of each importer of such drug or device in the United States that is known to the establishment, and the name of each person who imports or offers for import such drug or device to the United States for purposes of importation; and”.
Subsec. (i)(1)(B). 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—
Subsec. (i)(4). Pub. L. 112–144, § 702(b)(2), added par. (4).
Subsec. (j)(1)(E). Pub. L. 112–144, § 703(1), added subpar. (E).
Subsec. (j)(4). Pub. L. 112–144, § 703(2), added par. (4).
Subsec. (n). Pub. L. 112–144, § 604, designated existing provisions as par. (1) and added par. (2).
Subsec. (p). Pub. L. 112–144, § 704, inserted subsec. heading, designated existing provisions as par. (1) and inserted par. heading, and added pars. (2) and (3).
2007—Subsec. (b). 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).
Subsec. (i)(1). 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 offered for import into the United States.
Subsec. (j)(2). 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 regard to devices once each year during the period beginning on October 1 and ending on December 31, the following information:” for “Each person who registers with the Secretary under this section shall report to the Secretary once during the month of June of each year and once during the month of December of each year the following information:”.
Subsec. (k). Pub. L. 110–85, § 801(b)(3)(C), inserted concluding provisions.
Subsec. (p). 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 a finding by the Secretary that the electronic receipt of such registrations is feasible, unless the Secretary grants a request for waiver of such requirement because use of electronic means is not reasonable for the person requesting such waiver.”
2004—Subsec. (o)(1)(B), (2)(B). Pub. L. 108–214, § 2(c)(2)(A), (B)(i), substituted “or adulterated” for “, adulterated”.
Subsec. (o)(2)(E). Pub. L. 108–214, § 2(c)(2)(B)(ii), substituted “semi-critical” for “semicritical”.
2002—Subsec. (h). 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”.
Subsec. (i)(1). 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 establishment, the name of the United States agent for the establishment, the name of each importer of such drug or device in the United States that is known to the establishment, and the name of each person who imports or offers for import such drug or device to the United States for purposes of importation” for “shall register with the Secretary the name and place of business of the establishment and the name of the United States agent for the establishment”.
Subsec. (j)(1). Pub. L. 107–188, § 321(a)(2), substituted “subsection (b), (c), (d), or (i)” for “subsection (b), (c), or (d)” in first sentence.
Subsec. (m)(1). 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.”
Subsec. (o). Pub. L. 107–250, § 302(b), added subsec. (o).
Subsec. (p). Pub. L. 107–250, § 207, added subsec. (p).
1997—Subsec. (g). 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 of the device to the ultimate consumer or user.”
Subsec. (g)(4), (5). Pub. L. 105–115, § 213(b)(1), (2), added par. (4) and redesignated former par. (4) as (5).
Subsec. (i). 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 permitted to register under this section pursuant to regulations promulgated by the Secretary. Such regulations shall require such establishment to provide the information required by subsection (j) of this section and shall require such establishment to provide the information required by subsection (j) of this section in the case of a device or devices and shall include provisions for registration of any such establishment upon condition that adequate and effective means are available, by arrangement with the government of such foreign country or otherwise, to enable the Secretary to determine from time to time whether drugs or devices manufactured, prepared, propagated, compounded, or processed in such establishment, if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in section 381(a) of this title.”
Subsec. (j)(1)(A), (D). Pub. L. 105–115, § 125(a)(2)(C), struck out “, 356, 357,” before “or 360b of this title”.
Subsec. (k). 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”.
Subsecs. (l), (m). Pub. L. 105–115, § 206(a)(2), added subsecs. (l) and (m).
Subsec. (n). Pub. L. 105–115, § 209(a), added subsec. (n).
1976—Subsec. (a)(1). 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”.
Subsecs. (b) to (d). Pub. L. 94–295, § 4(a)(3), inserted “or a device or devices” after “drug or drugs”.
Subsec. (e). 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 devices in accordance with the system.
Subsec. (g)(1) to (3). Pub. L. 94–295, § 4(a)(5), substituted “drugs or devices” for “drugs”.
Subsec. (h). 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.
Subsec. (i). 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.
Subsec. (j)(1). 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 its established name” for “a list of all drugs (by established name” and “drugs or devices filed” for “drugs filed”.
Subsec. (j)(1)(A). 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 section 360e of this title,” after “360b of this title,”, and substituted “such drug or device” for “such drug” wherever appearing.
Subsec. (j)(1)(B). 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”.
Subsec. (j)(1)(B)(i). 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 made by the Secretary for good cause, a copy of all advertisements for a particular drug product or device, or” for “which is subject to section 353(b)(1) of this title, a copy of all labeling for such drug, a representative sampling of advertisements for such drug, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular drug product, or”.
Subsec. (j)(1)(B)(ii). 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” for “which is not subject to section 353(b)(1) of this title, the label and package insert for such drug and a representative sampling of any other labeling for such drug”.
Subsec. (j)(1)(C). Pub. L. 94–295, § 4(a)(8)(F), substituted “an applicable list” for “such list”.
Subsec. (j)(1)(D). 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 “or 360b of this title,”, and substituted “particular drug product or device” for “particular drug product” wherever appearing.
Subsec. (j)(2). 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).
Subsec. (k). Pub. L. 94–295, § 4(a)(9), added subsec. (k).
1972—Subsec. (e). 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).
Subsec. (f). 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.
Subsec. (i). Pub. L. 92–387, § 4(c), inserted provision that the regulations shall require such establishment to provide the information required by subsec. (j).
Subsec. (j). Pub. L. 92–387, § 3, added subsec. (j).
1965—Pub. L. 89–74, § 4(e), included certain wholesalers in section catchline.
Subsec. (a)(2), (3). Pub. L. 89–74, § 4(a), added par. (2) and redesignated former par. (2) as (3).
Subsecs. (b), (c). 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.
Subsec. (d). 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, and added par. (2).
Pub. L. 92–387, § 5, Aug. 16, 1972, 86 Stat. 562, provided that: “The amendments made by this Act [amending this section and sections 331 and 335 of this title and enacting provisions set out below] shall take effect on the first day of the sixth month beginning after the date of enactment of this Act [Aug. 16, 1972].”
Pub. L. 114–255, div. A, title III, § 3059(b), Dec. 13, 2016, 130 Stat. 1130, provided that: “The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue final guidance regarding when a premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) is required to be submitted for a modification or change to a legally marketed device. Such final guidance shall be issued not later than 1 year after the date on which the comment period closes for the draft guidance on such subject.”
Pub. L. 92–387, § 2, Aug. 16, 1972, 86 Stat. 559, provided that: “The Federal Government which is responsible for regulating drugs has no ready means of determining what drugs are actually being manufactured or packed by establishments registered under the Federal Food, Drug, and Cosmetic Act [this chapter] except by periodic inspection of such registered establishments. Knowledge of which particular drugs are being manufactured or packed by each registered establishment would substantially assist in the enforcement of Federal laws requiring that such drugs be pure, safe, effective, and properly labeled. Information on the discontinuance of a particular drug could serve to alleviate the burden of reviewing and implementing enforcement actions against drugs which, although commercially discontinued, remain active for regulatory purposes. Information on the type and number of different drugs being manufactured or packed by drug establishments could permit more effective and timely regulation by the agencies of the Federal Government responsible for regulating drugs, including identification of which drugs in interstate commerce are subject to section 505 or 507 [section 355 or 357 of this title], or to other provisions of the Federal Food, Drug, and Cosmetic Act.”
Pub. L. 87–781, title III, § 301, Oct. 10, 1962, 76 Stat. 793, provided that: “The Congress hereby finds and declares that in order to make regulation of interstate commerce in drugs effective, it is necessary to provide for registration and inspection of all establishments in which drugs are manufactured, prepared, propagated, compounded, or processed; that the products of all such establishments are likely to enter the channels of interstate commerce and directly affect such commerce; and that the regulation of interstate commerce in drugs without provision for registration and inspection of establishments that may be engaged only in intrastate commerce in such drugs would discriminate against and depress interstate commerce in such drugs, and adversely burden, obstruct, and affect such interstate commerce.”
Pub. L. 87–781, title III, § 303, Oct. 10, 1962, 76 Stat. 795, provided that any person who, on the day immediately preceding Oct. 10, 1962, owned or operated an establishment which manufactured or processed drugs, registered before the first day of the seventh month following October, 1962, would be deemed to be registered in accordance with subsec. (b) of this section for the calendar year 1962 and if registered within this period and effected in 1963, be deemed in compliance for that calendar year.
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 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 99 - DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES21 CFR Part 201 - LABELING21 CFR Part 203 - PRESCRIPTION DRUG MARKETING21 CFR Part 206 - IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE21 CFR Part 207 - REQUIREMENTS FOR FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS, AND THE NATIONAL DRUG CODE21 CFR Part 208 - MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS21 CFR Part 225 - CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS21 CFR Part 330 - OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED21 CFR Part 331 - ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE21 CFR Part 332 - ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 333 - TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 335 - ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 336 - ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 338 - NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 340 - STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 341 - COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 343 - INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 344 - TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 346 - ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 347 - SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 348 - EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 349 - OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 350 - ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 352 - SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]21 CFR Part 355 - ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 357 - MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 358 - MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 571 - FOOD ADDITIVE PETITIONS21 CFR Part 600 - BIOLOGICAL PRODUCTS: GENERAL21 CFR Part 601 - LICENSING21 CFR Part 606 - CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS21 CFR Part 606 - CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS21 CFR Part 607 - ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES21 CFR Part 610 - GENERAL BIOLOGICAL PRODUCTS STANDARDS21 CFR Part 630 - REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE21 CFR Part 640 - ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS21 CFR Part 660 - ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS21 CFR Part 680 - ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS21 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 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 821 - MEDICAL DEVICE TRACKING REQUIREMENTS21 CFR Part 830 - UNIQUE DEVICE IDENTIFICATION21 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 874 - EAR, NOSE, AND THROAT 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 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