21 U.S.C. § 360 — Registration of producers of drugs or de-

Page 301 TITLE 21—FOOD AND DRUGS § 360 1 So in original. sections 358 to 360 of this title, amended sections 351 to 353, 355, and 357 of this title, and enacted provisions set out as notes under sections 352, 355, 358, and 360 of this title. The Drug Amendments of 1962, referred to in text, is Pub. L. 87–781, Oct. 10, 1962, 76 Stat. 780, as amended. For complete classification of this Act to the Code, see Short Title of 1962 Amendment note set out under sec- tion 301 of this title and Tables. § 360. Registration of producers of drugs or de- vices (a) Definitions As used in this section— (1) the term ‘‘manufacture, preparation, propagation, compounding, or processing’’ shall include repackaging or otherwise chang- ing the container, wrapper, or labeling of any drug package or device package in furtherance of the distribution of the drug or device from the original place of manufacture to the per- son who makes final delivery or sale to the ul- timate consumer or user; and (2) the term ‘‘name’’ shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation. (b) Annual registration (1) 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, prepa- ration, propagation, compounding, or processing of a drug or drugs shall register with the Sec- retary the name of such person, places of busi- ness of such person, all such establishments, the unique facility identifier of each such establish- ment, and a point of contact e-mail address. (2) 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, prepa- ration, propagation, compounding, or processing of a device or devices shall register with the Secretary his name, places of business, and all such establishments. (3) The Secretary shall specify the unique fa- cility identifier system that shall be used by registrants under paragraph (1). The require- ment to include a unique facility identifier in a registration under paragraph (1) shall not apply until the date that the identifier system is spec- ified by the Secretary under the preceding sen- tence. (c) New producers Every person upon first engaging in the manu- facture, preparation, propagation, compounding, or processing of a drug or drugs or a device or devices in any establishment which he owns or operates in any State shall immediately register with the Secretary— (1) with respect to drugs, the information de- scribed under subsection (b)(1); and (2) with respect to devices, the information described under subsection (b)(2)..1 (d) Additional establishments Every person duly registered in accordance with the foregoing subsections of this section shall immediately register with the Secretary any additional establishment which he owns or operates in any State and in which he begins the manufacture, preparation, propagation, compounding, or processing of a drug or drugs or a device or devices. (e) Registration number; uniform system for identification of devices intended for human use The Secretary may assign a registration num- ber to any person or any establishment reg- istered in accordance with this section. The Sec- retary may also assign a listing number to each drug or class of drugs listed under subsection (j). Any number assigned pursuant to the preceding sentence shall be the same as that assigned pur- suant to the National Drug Code. The Secretary may by regulation prescribe a uniform system for the identification of devices intended for human use and may require that persons who are required to list such devices pursuant to sub- section (j) shall list such devices in accordance with such system. (f) Availability of registrations for inspection The Secretary shall make available for inspec- tion, to any person so requesting, any registra- tion filed pursuant to this section; except that any list submitted pursuant to paragraph (3) of subsection (j) and the information accom- panying any list or notice filed under paragraph (1) or (2) of that subsection shall be exempt from such inspection unless the Secretary finds that such an exemption would be inconsistent with protection of the public health. (g) Exclusions from application of section The foregoing subsections of this section shall not apply to— (1) pharmacies which maintain establish- ments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their busi- ness of dispensing or selling drugs or devices at retail; (2) practitioners licensed by law to prescribe or administer drugs or devices and who manu- facture, prepare, propagate, compound, or process drugs or devices solely for use in the course of their professional practice; (3) persons who manufacture, prepare, propa- gate, compound, or process drugs or devices solely for use in research, teaching, or chem- ical analysis and not for sale; (4) any distributor who acts as a wholesale distributor of devices, and who does not manu- facture, repackage, process, or relabel a de- vice; or (5) such other classes of persons as the Sec- retary may by regulation exempt from the ap- plication of this section upon a finding that registration by such classes of persons in ac- cordance with this section is not necessary for the protection of the public health. Page 302 TITLE 21—FOOD AND DRUGS § 360 2 So in original. The period probably should be a semicolon. In this subsection, the term ‘‘wholesale dis- tributor’’ means any person (other than the manufacturer or the initial importer) who dis- tributes a device from the original place of man- ufacture to the person who makes the final de- livery or sale of the device to the ultimate con- sumer or user. (h) Inspections (1) In general Every establishment that is required to be registered with the Secretary under this sec- tion shall be subject to inspection pursuant to section 374 of this title. (2) Risk-based schedule for devices (A) In general The Secretary, acting through one or more officers or employees duly designated by the Secretary, shall inspect establishments de- scribed in paragraph (1) that are engaged in the manufacture, propagation, compounding, or processing of a device or devices (referred to in this subsection as ‘‘device establishments’’) in accordance with a risk-based schedule established by the Sec- retary. (B) Factors and considerations In establishing the risk-based schedule under subparagraph (A), the Secretary shall— (i) apply, to the extent applicable for de- vice establishments, the factors identified in paragraph (4); and (ii) consider the participation of the de- vice establishment, as applicable, in inter- national device audit programs in which the United States participates or the United States recognizes for purposes of inspecting device establishments. (3) Risk-based schedule for drugs The Secretary, acting through one or more officers or employees duly designated by the Secretary, shall inspect establishments de- scribed in paragraph (1) that are engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs (referred to in this subsection as ‘‘drug estab- lishments’’) in accordance with a risk-based schedule established by the Secretary. (4) Risk factors In establishing a risk-based schedule under paragraph (2) or (3), the Secretary shall in- spect establishments according to the known safety risks of such establishments, which shall be based on the following factors: (A) The compliance history of the estab- lishment. (B) The record, history, and nature of re- calls linked to the establishment. (C) The inherent risk of the drug or device manufactured, prepared, propagated, com- pounded, or processed at the establishment. (D) The inspection frequency and history of the establishment, including whether the establishment has been inspected pursuant to section 374 of this title within the last 4 years. (E) Whether the establishment has been inspected by a foreign government or an agency of a foreign government recognized under section 384e of this title. (F) The compliance history of establish- ments in the country or region in which the establishment is located that are subject to regulation under this chapter, including the history of violations related to products ex- ported from such country or region that are subject to such regulation. (G) Any other criteria deemed necessary and appropriate by the Secretary for pur- poses of allocating inspection resources. (5) Effect of status In determining the risk associated with an establishment for purposes of establishing a risk-based schedule under paragraph (3), the Secretary shall not consider whether the drugs manufactured, prepared, propagated, com- pounded, or processed by such establishment are drugs described in section 353(b) of this title. (6) Annual report on inspections of establish- ments Not later than May 1 of each year, the Sec- retary shall make available on the Internet Web site of the Food and Drug Administration a report regarding— (A)(i) the number of domestic and foreign establishments registered pursuant to this section in the previous fiscal year; (ii) the number of such registered estab- lishments in each region of interest; (iii) the number of such domestic estab- lishments and the number of such foreign es- tablishments, including the number of estab- lishments in each region of interest, that the Secretary inspected in the previous fiscal year; (iv) the number of inspections to support actions by the Secretary on applications under section 355 of this title or section 262 of title 42, including the number of inspec- tions to support actions by the Secretary on supplemental applications, including changes to manufacturing processes, the Secretary conducted in the previous fiscal year; (v) the number of routine surveillance in- spections the Secretary conducted in the previous fiscal year, including in each region of interest; (vi) the number of for-cause inspections the Secretary conducted in the previous fis- cal year, not including inspections described in clause (iv), including in each region of in- terest; and (vii) the number of inspections the Sec- retary has recognized pursuant to an agree- ment entered into pursuant to section 384e of this title, or otherwise recognized, for each of the types of inspections described in clauses (v) and (vi), including for inspections of establishments in each region of interest.2 (B) 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; Page 303 TITLE 21—FOOD AND DRUGS § 360 (C) the percentage of the budget of the Food and Drug Administration used to fund the inspections described under subpara- graph (A); and (D) the status of the efforts of the Food and Drug Administration to expand its rec- ognition of inspections conducted or recog- nized by foreign regulatory authorities under section 384e of this title, including any obstacles to expanding the use of such rec- ognition. (7) Region of interest For purposes of paragraph (6)(A), the term ‘‘region of interest’’ means a foreign geo- graphic region or country, including the Peo- ple’s Republic of China, India, the European Union, the United Kingdom, and any other country or geographic region, as the Secretary determines appropriate. (i) Registration of foreign establishments (1) Every person who owns or operates any es- tablishment 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— (A) upon first engaging in any such activity, immediately submit a registration to the Sec- retary that includes— (i) with respect to drugs, the name and place of business of such person, all such es- tablishments, the unique facility identifier of each such establishment, a point of con- tact e-mail address, the name of the United States agent of each such establishment, the name of each importer of such drug in the United States that is known to the estab- lishment, and the name of each person who imports or offers for import such drug to the United States for purposes of importation; and (ii) with respect to devices, the name and place of business of the establishment, the name of the United States agent for the es- tablishment, the name of each importer of such device in the United States that is known to the establishment, and the name of each person who imports or offers for im- port such device to the United States for purposes of importation; and (B) each establishment subject to the re- quirements of subparagraph (A) shall there- after register with the Secretary during the period beginning on October 1 and ending on December 31 of each year. (2) The establishment shall also provide the information required by subsection (j). (3) The Secretary is authorized to enter into cooperative arrangements with officials of for- eign countries to ensure that adequate and ef- fective means are available for purposes of de- termining, 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 re- fused admission on any of the grounds set forth in section 381(a) of this title. (4) The Secretary shall specify the unique fa- cility identifier system that shall be used by registrants under paragraph (1) with respect to drugs. The requirement to include a unique fa- cility identifier in a registration under para- graph (1) with respect to drugs shall not apply until the date that the identifier system is spec- ified by the Secretary under the preceding sen- tence. (5) The requirements of paragraphs (1) and (2) shall apply regardless of whether the drug or de- vice undergoes further manufacture, prepara- tion, propagation, compounding, or processing at a separate establishment outside the United States prior to being imported or offered for im- port into the United States. (j) Filing of lists of drugs and devices manufac- tured, prepared, propagated and com- pounded by registrants; statements; accom- panying disclosures (1) Every person who registers with the Sec- retary under subsection (b), (c), (d), or (i) shall, at the time of registration under any such sub- section, file with the Secretary a list of all drugs and a list of all devices and a brief state- ment 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 list- ed by its established name (as defined in section 352(e) of this title) and by any proprietary name) which are being manufactured, prepared, propa- gated, compounded, or processed by him for commercial distribution and which he has not included in any list of drugs or devices filed by him with the Secretary under this paragraph or paragraph (2) before such time of registration. Such list shall be prepared in such form and manner as the Secretary may prescribe and shall be accompanied by— (A) in the case of a drug contained in the ap- plicable list and subject to section 355 or 360b of this title, or a device intended for human use contained in the applicable list with re- spect to which a performance standard has been established under section 360d of this title or which is subject to section 360e of this title, a reference to the authority for the mar- keting of such drug or device and a copy of all labeling for such drug or device; (B) in the case of any other drug or device contained in an applicable list— (i) 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 adver- tisements for such drug or device, and, upon request made by the Secretary for good cause, a copy of all advertisements for a par- ticular drug product or device, or (ii) 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 in- sert for such drug or device and a represent- ative sampling of any other labeling for such drug or device; (C) in the case of any drug contained in an applicable list which is described in subpara- graph (B), a quantitative listing of its active ingredient or ingredients, except that with re- spect to a particular drug product the Sec- Page 304 TITLE 21—FOOD AND DRUGS § 360 retary may require the submission of a quan- titative listing of all ingredients if he finds that such submission is necessary to carry out the purposes of this chapter; (D) if the registrant filing a list has deter- mined that a particular drug product or device contained in such list is not subject to section 355 or 360b of this title, or the particular de- vice contained in such list is not subject to a performance standard established under sec- tion 360d of this title or to section 360e of this title or is not a restricted device a brief state- ment of the basis upon which the registrant made such determination if the Secretary re- quests such a statement with respect to that particular drug product or device; and (E) in the case of a drug contained in the ap- plicable list, the name and place of business of each manufacturer of an excipient of the listed drug with which the person listing the drug conducts business, including all establish- ments used in the production of such excip- ient, the unique facility identifier of each such establishment, and a point of contact e-mail address for each such excipient manufacturer. (2) Each person who registers with the Sec- retary under this section shall report to the Sec- retary, 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 re- gard to devices once each year during the period beginning on October 1 and ending on December 31, the following information: (A) A list of each drug or device introduced by the registrant for commercial distribution which has not been included in any list pre- viously filed by him with the Secretary under this subparagraph or paragraph (1) of this sub- section. 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). (B) 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 Feb- ruary 1, 1973) he has discontinued the manu- facture, 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 iden- tity (by established name (as defined in sec- tion 352(e) of this title) and by any proprietary name) of such drug or device. (C) If since the date the registrant reported pursuant to subparagraph (B) a notice of dis- continuance he has resumed the manufacture, preparation, propagation, compounding, or processing for commercial distribution of the drug or device with respect to which such no- tice of discontinuance was reported; notice of such resumption, the date of such resumption, the identity of such drug or device (each by es- tablished 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 re- ported such resumption to the Secretary pur- suant to this subparagraph. (D) Any material change in any information previously submitted pursuant to this para- graph or paragraph (1). (3)(A) Each person who registers with the Sec- retary under this section with regard to a drug shall report annually to the Secretary on the amount of each drug listed under paragraph (1) that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution. Such information may be required to be submitted in an electronic for- mat as determined by the Secretary. The Sec- retary may require that information required to be reported under this paragraph be submitted at the time a public health emergency is de- clared by the Secretary under section 247d of title 42. (B) By order of the Secretary, certain biologi- cal products or categories of biological products regulated under section 262 of title 42 may be ex- empt from some or all of the reporting require- ments under subparagraph (A), if the Secretary determines that applying such reporting re- quirements to such biological products or cat- egories of biological products is not necessary to protect the public health. (4) The Secretary may also require each reg- istrant under this section to submit a list of each drug product which (A) the registrant is manufacturing, preparing, propagating, compounding, or processing for commercial dis- tribution, and (B) contains a particular ingre- dient. The Secretary may not require the sub- mission of such a list unless he has made a find- ing that the submission of such a list is nec- essary to carry out the purposes of this chapter. (5) The Secretary shall require persons subject to this subsection to use, for purposes of this subsection, the unique facility identifier sys- tems specified under subsections (b)(3) and (i)(4) with respect to drugs. Such requirement shall not apply until the date that the identifier sys- tem under subsection (b)(3) or (i)(4), as applica- ble, is specified by the Secretary. (k) Report preceding introduction of devices into interstate commerce Each person who is required to register under this section and who proposes to begin the intro- duction or delivery for introduction into inter- state 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)— (1) the class in which the device is classified under section 360c of this title or if such per- son determines that the device is not classi- fied under such section, a statement of that determination and the basis for such person’s determination that the device is or is not so classified, and (2) action taken by such person to comply with requirements under section 360d or 360e of this title which are applicable to the device. A notification submitted under this subsection that contains clinical trial data for an applica- ble device clinical trial (as defined in section Page 305 TITLE 21—FOOD AND DRUGS § 360 282(j)(1) of title 42) shall be accompanied by the certification required under section 282(j)(5)(B) of such title. Such certification shall not be con- sidered an element of such notification. (l) Exemption from reporting requirements (1) A report under subsection (k) is not re- quired for a device intended for human use that is exempted from the requirements of this sub- section under subsection (m) or is within a type that has been classified into class I under sec- tion 360c of this title, or with respect to a change that is consistent with a predetermined change control plan cleared under section 360e–4 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 sub- stantial importance in preventing impairment of human health, or to any class I device that presents a potential unreasonable risk of illness or injury. (2) Not later than 120 calendar days after De- cember 13, 2016, and at least once every 5 years thereafter, as the Secretary determines appro- priate, the Secretary shall identify, through publication in the Federal Register, any type of class I device that the Secretary determines no longer requires a report under subsection (k) to provide reasonable assurance of safety and effec- tiveness. Upon such publication— (A) each type of class I device so identified shall be exempt from the requirement for a re- port under subsection (k); and (B) the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption. (m) List of exempt class II devices; initial and final determinations by Secretary; publica- tion in Federal Register (1) The Secretary shall— (A) not later than 90 days after December 13, 2016, and at least once every 5 years there- after, as the Secretary determines appro- priate— (i) publish in the Federal Register a notice that contains a list of each type of class II device that the Secretary determines no longer requires a report under subsection (k) to provide reasonable assurance of safety and effectiveness; and (ii) 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 (B) not later than 210 calendar days after De- cember 13, 2016, publish in the Federal Reg- ister a list representing the Secretary’s final determination with respect to the devices con- tained in the list published under subpara- graph (A). (2) 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 ex- empt 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 in- terested person, if the Secretary determines that such report is not necessary to assure the safety and effectiveness of the device. The Sec- retary shall publish in the Federal Register no- tice of the intent of the Secretary to exempt the device, or of the petition, and provide a 60-cal- endar-day period for public comment. Within 120 days after the issuance of the notice in the Fed- eral 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 pe- tition shall be deemed to be granted. (3) Upon the publication of the final list under paragraph (1)(B)— (A) each type of class II device so listed shall be exempt from the requirement for a report under subsection (k); and (B) the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption. (n) Review of report; time for determination by Secretary (1) The Secretary shall review the report re- quired in subsection (k) and make a determina- tion under section 360c(f)(1) of this title not later than 90 days after receiving the report. (2)(A) Not later than 18 months after July 9, 2012, the Secretary shall submit to the Com- mittee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report regarding when a premarket notification under subsection (k) should be submitted for a modification or change to a legally marketed device. The report shall include the Secretary’s interpretation of the following terms: ‘‘could significantly affect the safety or effectiveness of the device’’, ‘‘a significant change or modifica- tion in design, material, chemical composition, energy source, or manufacturing process’’, and ‘‘major change or modification in the intended use of the device’’. The report also shall discuss possible processes for industry to use to deter- mine whether a new submission under sub- section (k) is required and shall analyze how to leverage existing quality system requirements to reduce premarket burden, facilitate continual device improvement, and provide reasonable as- surance of safety and effectiveness of modified devices. In developing such report, the Secretary shall consider the input of interested stake- holders. (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 pre- market review or any compliance or enforce- ment decisions or actions. The Secretary shall not issue— (i) any draft guidance or proposed regulation that addresses when to submit a premarket notification submission for changes and modi- fications made to a manufacturer’s previously cleared device before the receipt by the Com- mittee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate of the report required in subparagraph (A); and Page 306 TITLE 21—FOOD AND DRUGS § 360 (ii) any final guidance or regulation on that topic for one year after date of receipt of such report by the Committee on Energy and Com- merce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate. (C) The Food and Drug Administration guid- ance entitled ‘‘Deciding When to Submit a 510(k) for a Change to an Existing Device’’, dated Jan- uary 10, 1997, shall be in effect until the subse- quent issuance of guidance or promulgation, if appropriate, of a regulation described in sub- paragraph (B), and the Secretary shall interpret such guidance in a manner that is consistent with the manner in which the Secretary has in- terpreted such guidance since 1997. (o) Reprocessed single-use devices (1) With respect to reprocessed single-use de- vices for which reports are required under sub- section (k): (A) 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 Sec- retary, regarding cleaning and sterilization, and functional performance demonstrating that the single-use device will remain substan- tially equivalent to its predicate device after the maximum number of times the device is reprocessed as intended by the person submit- ting 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. (B) In the case of each report under sub- section (k) that was submitted to the Sec- retary before the publication of the initial list under subparagraph (A), or any revision there- of, and was for a device or type of device in- cluded 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. Dur- ing 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 Sec- retary, 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 termi- nated 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 with- drawn, the device can no longer be legally marketed. (C) 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 ad- vance of revising the list under subparagraph (A) to include such type, require that the re- port include the validation data specified in subparagraph (A). (D) Section 352(o) of this title applies with respect to the failure of a report under sub- section (k) to include validation data required under subparagraph (A). (2) With respect to critical or semi-critical re- processed single-use devices that, under sub- section (l) or (m), are exempt from the require- ment of submitting reports under subsection (k): (A) The Secretary shall identify such devices or types of devices for which such exemptions should be terminated in order to provide a rea- sonable assurance of the safety and effective- ness of the devices. The Secretary shall pub- lish in the Federal Register a list of the de- vices or types of devices so identified, and shall revise the list as appropriate. The ex- emption 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 de- scribed in paragraph (1)(A). (B) For each device or type of device in- cluded 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 re- vision of the list, whichever terminates the ex- emption 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 sub- mitted to the Secretary. After the submission of the report to the Secretary the Secretary may not determine that the device is mis- branded 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 with- drawal of the submission; (ii) the Secretary determines by order that the device is sub- stantially 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. (C) In the case of semi-critical devices, the initial list under subparagraph (A) shall be published not later than 18 months after the effective date of this subsection. In the case of critical devices, the initial list under such sub- paragraph shall be published not later than six months after such effective date. (D) Section 352(o) of this title applies with respect to the failure to submit a report under Page 307 TITLE 21—FOOD AND DRUGS § 360 3 So in original. Probably should be ‘‘paragraph (1),’’. subsection (k) that is required pursuant to subparagraph (A), including a failure of the re- port to include validation data required in such subparagraph. (E) 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 de- vice. (p) Electronic registration and listing (1) In general Registrations and listings under this section (including the submission of updated informa- tion) shall be submitted to the Secretary by electronic means unless the Secretary grants a request for waiver of such requirement be- cause use of electronic means is not reason- able for the person requesting such waiver. (2) Electronic database Not 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 sub- section (f), populated with the information submitted as described under paragraph (1) that— (A) enables personnel of the Food and Drug Administration to search the database by any field of information submitted in a reg- istration described under paragraph (1), or combination of such fields; and (B) uses the unique facility identifier sys- tem to link with other relevant databases within the Food and Drug Administration, including the database for submission of in- formation under section 381(r) of this title. (3) Risk-based information and coordination The Secretary shall ensure the accuracy and coordination of relevant Food and Drug Ad- ministration databases in order to identify and inform risk-based inspections under sub- section (h). (q) Reusable medical devices (1) In general Not 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— (A) instructions for use, which have been validated in a manner specified by the Sec- retary; and (B) validation data, the types of which shall be specified by the Secretary; regarding cleaning, disinfection, and steriliza- tion, and for which a substantial equivalence determination may be based. (2) Revision of list The Secretary shall revise the list under paragraph (2),3 as the Secretary determines appropriate, with notice in the Federal Reg- ister. (3) Content of reports Reports under subsection (k) that are sub- mitted after the publication of the list de- scribed in paragraph (1), for devices or types of devices included on such list, shall include such instructions for use and validation data. (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; Pub. L. 115–52, title VII, § 701(a), title IX, § 901(e), Aug. 18, 2017, 131 Stat. 1054, 1076; Pub. L. 116–136, div. A, title III, § 3112(e), Mar. 27, 2020, 134 Stat. 363; Pub. L. 117–328, div. FF, title II, §§ 2511(a), 2515(a)(3), title III, §§ 3308(b)(1), 3613(a), 3616(c), Dec. 29, 2022, 136 Stat. 5803, 5806, 5836, 5872, 5875.) Editorial Notes REFERENCES IN TEXT The effective date of this subsection, referred to in subsec. (o)(2)(C), probably means the date of the enact- ment of Pub. L. 107–250, which enacted subsec. (o) of this section and was approved Oct. 26, 2002. AMENDMENTS 2022—Subsec. (h)(4)(F), (G). Pub. L. 117–328, § 3613(a), added subpar. (F) and redesignated former subpar. (F) as (G). Subsec. (h)(6). Pub. L. 117–328, § 3616(c)(1)(A), sub- stituted ‘‘Not’’ for ‘‘Beginning in 2014, not’’ in introduc- tory provisions. Subsec. (h)(6)(A). Pub. L. 117–328, § 3616(c)(1)(B), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: ‘‘(A)(i) the number of domestic and foreign establish- ments registered pursuant to this section in the pre- vious calendar year; and ‘‘(ii) the number of such domestic establishments and the number of such foreign establishments that the Secretary inspected in the previous calendar year;’’. Subsec. (h)(6)(D). Pub. L. 117–328, § 3616(c)(1)(C)–(E), added subpar. (D). Subsec. (h)(7). Pub. L. 117–328, § 3616(c)(2), added par. (7). Subsec. (i)(5). Pub. L. 117–328, § 2511(a), added par. (5). Subsec. (j)(3) to (5). 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. Subsec. (l)(1). 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 sec- tion 360e–4 of this title’’ after ‘‘section 360c of this title’’. 2020—Subsec. (j)(3) to (5). 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. 2017—Subsec. (h)(2). Pub. L. 115–52, § 701(a)(1), added par. (2) and struck out former par. (2). Prior to amend- ment, text read as follows: ‘‘Every establishment de- scribed in paragraph (1), in any State, that is engaged Page 308 TITLE 21—FOOD AND DRUGS § 360 in the manufacture, propagation, compounding, or processing of a device or devices classified in class II or III shall be so inspected by one or more officers or em- ployees duly designated by the Secretary, or by persons accredited to conduct inspections under section 374(g) of this title, at least once in the 2-year period begin- ning with the date of registration of such establish- ment pursuant to this section and at least once in every successive 2-year period thereafter.’’ Subsec. (h)(4). Pub. L. 115–52, § 701(a)(2)(A), sub- stituted ‘‘paragraph (2) or (3)’’ for ‘‘paragraph (3)’’ in introductory provisions. Subsec. (h)(4)(C). Pub. L. 115–52, § 701(a)(2)(B), inserted ‘‘or device’’ after ‘‘drug’’. Subsec. (h)(6). Pub. L. 115–52, § 901(e), substituted ‘‘May 1’’ for ‘‘February 1’’ in introductory provisions. 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 fin- ished 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 exist- ing 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 re- port under subsection (k) to provide reasonable assur- ance 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 pub- lication of the list in the Federal Register. The Sec- retary 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 revi- sion of the list by the Secretary.’’ Subsec. (m)(2). Pub. L. 114–255, § 3054(b)(2)(B), sub- stituted ‘‘60-calendar-day period’’ for ‘‘30-day period’’. Pub. L. 114–255, § 3054(b)(2)(A), which directed the sub- stitution of ‘‘1 calendar day after the date of publica- tion of the final list under paragraph (1)(B),’’ for ‘‘1 day after the date of publication of a list under this sub- section,’’, 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 Con- gress. 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 be- fore’ and all that follows through the period at the end and inserting the following: ‘During the period begin- ning on October 1 and ending on December 31 of each year, every person who owns or operates any establish- ment in any State engaged in the manufacture, prepa- ration, 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 ‘‘ad- dress.’’, 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 en- gaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary his name, places of busi- ness, 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 Sec- retary his name, place of business, and such establish- ment’’. 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 em- ployees 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 begin- ning with the date of registration of such establish- ment 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 amend- ment, text read as follows: ‘‘Any establishment within any foreign country engaged in the manufacture, prep- aration, 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), amend- ed 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 im- port such drug or device to the United States for pur- poses of importation; and’’. Subsec. (i)(1)(B). Pub. L. 112–144, § 702(b)(1)(C), amend- ed subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: ‘‘each establishment subject to the requirements of subparagraph (A) shall thereafter— ‘‘(i) with respect to drugs, register with the Sec- retary on or before December 31 of each year; and ‘‘(ii) with respect to devices, register with the Sec- retary during the period beginning on October 1 and ending on December 31 of each year.’’ Subsec. (i)(4). Pub. L. 112–144, § 702(b)(2), added par. (4). Subsec. (j)(1)(E). Pub. L. 112–144, § 703(1), added sub- par. (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 re- lated to registration requirement for foreign establish- ments engaged in the manufacture, preparation, propa- gation, 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 informa- tion:’’ for ‘‘Each person who registers with the Sec- retary 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 fol- lowing information:’’. Page 309 TITLE 21—FOOD AND DRUGS § 360 Subsec. (k). Pub. L. 110–85, § 801(b)(3)(C), inserted con- cluding provisions. Subsec. (p). Pub. L. 110–85, § 224, amended subsec. (p) generally. Prior to amendment, subsec. (p) read as fol- lows: ‘‘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 rea- sonable 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), sub- stituted ‘‘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 des- ignated by the Secretary’’. Subsec. (i)(1). Pub. L. 107–188, § 321(a)(1), substituted ‘‘On or before December 31 of each year, any establish- ment’’ 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 establish- ment’’. 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 dis- tributor’ means any person (other than the manufac- turer 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 fol- lows: ‘‘Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs, or a de- vice or devices, shall be permitted to register under this section pursuant to regulations promulgated by the Secretary. Such regulations shall require such es- tablishment to provide the information required by subsection (j) of this section and shall require such es- tablishment 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, prop- agated, compounded, or processed in such establish- ment, 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 sub- secs. (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), sub- stituted ‘‘drug package or device package’’ for ‘‘drug package’’, ‘‘distribution of the drug or device’’ for ‘‘dis- tribution 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), sub- stituted ‘‘drugs or devices’’ for ‘‘drugs’’. Subsec. (h). Pub. L. 94–295, § 4(a)(6), inserted reference to establishments engaged in the manufacture, propa- gation, 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 re- quired 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 introduc- tory 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 de- vice 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), sub- stituted ‘‘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 intro- ductory provisions substituted ‘‘drug or device con- tained in an applicable list’’ for ‘‘drug contained in such list’’. Subsec. (j)(1)(B)(i). Pub. L. 94–295, § 4(a)(8)(D), sub- stituted ‘‘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 sec- tion 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 par- ticular drug product, or’’. Subsec. (j)(1)(B)(ii). Pub. L. 94–295, § 4(a)(8)(E), sub- stituted ‘‘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 sec- tion 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), sub- stituted ‘‘an applicable list’’ for ‘‘such list’’. Subsec. (j)(1)(D). Pub. L. 94–295, § 4(a)(8)(G), sub- stituted ‘‘a list’’ for ‘‘the list’’, inserted ‘‘or the par- ticular 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 re- stricted device’’ after ‘‘or 360b of this title,’’, and sub- stituted ‘‘particular drug product or device’’ for ‘‘par- ticular 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 Page 310 TITLE 21—FOOD AND DRUGS § 360 (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 provi- sion 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 informa- tion submitted under subsec. (j)(1), (2) shall be exempt from inspection unless the Secretary determines other- wise. 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). 1970—Subsec. (a). Pub. L. 91–513 struck out provisions defining the wholesaling, jobbing, or distributing of de- pressant or stimulant drugs. Subsec. (b). Pub. L. 91–513 struck out provisions cov- ering establishments engaged in the wholesaling, job- bing, or distributing of depressant or stimulant drugs and the inclusion of the fact of such activity in the an- nual registration. Subsec. (c). Pub. L. 91–513 struck out provisions cov- ering 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. Subsec. (d). Pub. L. 91–513 struck out number designa- tion ‘‘(1)’’ preceding first sentence, struck out portion of such redesignated provisions covering the whole- saling, jobbing, or distributing of depressant or stimu- lant drugs, and struck out par. (2) covering the filing of supplemental registration whenever a person not pre- viously engaged or involved with depressant or stimu- lant drugs goes into the manufacturing, preparation, or processing thereof. 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 de- pressant or stimulant drug’’ after ‘‘drug or drugs’’ and inserted requirement that establishment indicate ac- tivity in depressant or stimulant drugs at time of reg- istration. Subsec. (d). Pub. L. 89–74 § 4(d), designated existing provisions as par. (1), inserted ‘‘or the wholesaling, job- bing, or distributing of any depressant or stimulant drug’’ and the requirement that the additional estab- lishment indicate activity in depressant or stimulant drugs at time of registration, and added par. (2). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2020 AMENDMENT Amendment by Pub. L. 116–136 effective 180 days after Mar. 27, 2020, see section 3112(g) of Pub. L. 116–136, set out as a note under section 356c of this title. EFFECTIVE DATE OF 2002 AMENDMENT Amendment by Pub. L. 107–188 effective upon the ex- piration of the 180-day period beginning June 12, 2002, see section 321(c) of Pub. L. 107–188, set out as a note under section 331 of this title. EFFECTIVE DATE OF 1997 AMENDMENT Amendment by sections 206(a), 209(a), 213(b), and 417 of Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title. EFFECTIVE DATE OF 1972 AMENDMENT 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 en- acting 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].’’ EFFECTIVE DATE OF 1970 AMENDMENT Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under section 801 of this title. EFFECTIVE DATE OF 1965 AMENDMENT Amendment by Pub. L. 89–74 effective Feb. 1, 1966, subject to registration with Secretary of names, places of business, establishments, and other prescribed infor- mation prior to Feb. 1, 1966, see section 11 of Pub. L. 89–74, set out as a note under section 321 of this title. UPDATING REGULATIONS Pub. L. 117–328, div. FF, title II, § 2511(b), Dec. 29, 2022, 136 Stat. 5804, provided that: ‘‘Not later than 2 years after the date of enactment of this Act [Dec. 29, 2022], the Secretary of Health and Human Services shall up- date regulations, as appropriate, to implement the amendment made by subsection (a) [amending this sec- tion].’’ SAVINGS PROVISION Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for any violation of law or any civil seizures or forfeitures and injunctive proceedings com- menced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in ac- cord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title. DEVICE MODIFICATIONS 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 guid- ance shall be issued not later than 1 year after the date on which the comment period closes for the draft guid- ance on such subject.’’ DECLARATION OF POLICY OF DRUG LISTING ACT OF 1972 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 [21 U.S.C. 301 et seq.] except by periodic inspection of such registered establishments. Knowledge of which particular drugs are being manu- factured or packed by each registered establishment would substantially assist in the enforcement of Fed- eral laws requiring that such drugs be pure, safe, effec- tive, and properly labeled. Information on the dis- continuance of a particular drug could serve to allevi- ate the burden of reviewing and implementing enforce- ment actions against drugs which, although commer- cially discontinued, remain active for regulatory pur- poses. Information on the type and number of different drugs being manufactured or packed by drug establish- ments could permit more effective and timely regula- tion by the agencies of the Federal Government respon- sible for regulating drugs, including identification of which drugs in interstate commerce are subject to sec- tion 505 or 507 [21 U.S.C. 355, 357], or to other provisions of the Federal Food, Drug, and Cosmetic Act.’’ CONGRESSIONAL DECLARATION OF NEED FOR REGISTRA- TION AND INSPECTION OF DRUG ESTABLISHMENTS Pub. L. 87–781, title III, § 301, Oct. 10, 1962, 76 Stat. 793, provided that: ‘‘The Congress hereby finds and declares Page 311 TITLE 21—FOOD AND DRUGS § 360a–1 that in order to make regulation of interstate com- merce 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 com- merce; and that the regulation of interstate commerce in drugs without provision for registration and inspec- tion 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 inter- state commerce.’’ REGISTRATION OF CERTAIN PERSONS OWNING OR OPER- ATING DRUG ESTABLISHMENTS PRIOR TO OCT. 10, 1962 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 establish- ment which manufactured or processed drugs, reg- istered before the first day of the seventh month fol- lowing 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. § 360a. Clinical trial guidance for antibiotic drugs (a) In general Not later than 1 year after September 27, 2007, the Secretary shall issue guidance for the con- duct of clinical trials with respect to antibiotic drugs, including antimicrobials to treat acute bacterial sinusitis, acute bacterial otitis media, and acute bacterial exacerbation of chronic bronchitis. Such guidance shall indicate the ap- propriate models and valid surrogate markers. (b) Review Not later than 5 years after September 27, 2007, the Secretary shall review and update the guid- ance described under subsection (a) to reflect de- velopments in scientific and medical informa- tion and technology. (June 25, 1938, ch. 675, § 511, as added Pub. L. 110–85, title IX, § 911, Sept. 27, 2007, 121 Stat. 951.) Editorial Notes PRIOR PROVISIONS A prior section 360a, act June 25, 1938, ch. 675, § 511, as added July 15, 1965, Pub. L. 89–74, § 3(b), 79 Stat. 227; amended Oct. 24, 1968, Pub. L. 90–639, § 2(a), 82 Stat. 1361, regulated the manufacture, compounding, and proc- essing of depressant and stimulant drugs and their sale, delivery, disposal, possession, and recordkeeping activi- ties connected therewith, prior to repeal by Pub. L. 91–513, title II, §§ 701(a), 704, Oct. 27, 1970, 84 Stat. 1281, 1284, effective on the first day of the seventh calendar month that began after Oct. 26, 1970. § 360a–1. Clinical trials (a) Review and revision of guidance documents (1) In general The Secretary of Health and Human Serv- ices (referred to in this section as the ‘‘Sec- retary’’) shall review and, as appropriate, re- vise not fewer than 3 guidance documents per year, which shall include— (A) reviewing the guidance documents of the Food and Drug Administration for the conduct of clinical trials with respect to antibacterial and antifungal drugs; and (B) as appropriate, revising such guidance documents to reflect developments in sci- entific and medical information and tech- nology and to ensure clarity regarding the procedures and requirements for approval of antibacterial and antifungal drugs under chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.). (2) Issues for review At a minimum, the review under paragraph (1) shall address the appropriate animal mod- els of infection, in vitro techniques, valid microbiological surrogate markers, the use of noninferiority versus superiority trials, trial enrollment, data requirements, and appro- priate delta values for noninferiority trials. (3) Rule of construction Except to the extent to which the Secretary makes revisions under paragraph (1)(B), noth- ing in this section shall be construed to repeal or otherwise effect the guidance documents of the Food and Drug Administration. (b) Recommendations for investigations (1) Request The sponsor of a drug intended to be des- ignated as a qualified infectious disease prod- uct may request that the Secretary provide written recommendations for nonclinical and clinical investigations which the Secretary be- lieves may be necessary to be conducted with the drug before such drug may be approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in treating, detecting, preventing, or identifying a qualifying pathogen, as defined in section 505E of such Act [21 U.S.C. 355f]. (2) Recommendations If the Secretary has reason to believe that a drug for which a request is made under this subsection is a qualified infectious disease product, the Secretary shall provide the per- son making the request written recommenda- tions for the nonclinical and clinical inves- tigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request, would be necessary for approval under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) of such drug for the use described in paragraph (1). (c) Qualified infectious disease product For purposes of this section, the term ‘‘quali- fied infectious disease product’’ has the meaning given such term in section 505E(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355f(g)], as added by section 801 of this Act. (Pub. L. 112–144, title VIII, § 804, July 9, 2012, 126 Stat. 1080.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a)(1)(B), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter.