Any requirement authorized by or under section 351, 352, 360, or 360i of this title applicable to a device intended for human use shall apply to such device until the applicability of the requirement to the device has been changed by action taken under section 360c, 360d, or 360e of this title or under subsection (g) of this section, and any requirement established by or under section 351, 352, 360, or 360i of this title which is inconsistent with a requirement imposed on such device under section 360d or 360e of this title or under subsection (g) of this section shall not apply to such device.
The requirements of sections 360d and 360e of this title shall not apply to a device that-
Paragraph (1) shall apply to a device only if-
Not later than 2 years after July 9, 2012, the Secretary shall issue final guidance on replication of multiple devices described in paragraph (2)(B).
Any information reported to or otherwise obtained by the Secretary or his representative under section 360c, 360d, 360e, 360f, 360h, 360i, or 374 of this title or under subsection (f) or (g) of this section which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5 by reason of subsection (b)(4) of such section shall be considered confidential and shall not be disclosed and may not be used by the Secretary as the basis for the reclassification of a device from class III to class II or class I or as the basis for the establishment or amendment of a performance standard under section 360d of this title for a device reclassified from class III to class II, except (1) in accordance with subsection (h), and (2) that such information may be disclosed to other officers or employees concerned with carrying out this chapter or when relevant in any proceeding under this chapter (other than section 360c or 360d of this title).
Each notice of proposed rulemaking under section 360c, 360d, 360e, 360f, 360h, or 360i of this title, or under this section, any other notice which is published in the Federal Register with respect to any other action taken under any such section and which states the reasons for such action, and each publication of findings required to be made in connection with rulemaking under any such section shall set forth-
if, because of its potentiality for harmful effect or the collateral measures necessary to its use, the Secretary determines that there cannot otherwise be reasonable assurance of its safety and effectiveness. No condition prescribed under subparagraph (B) may restrict the use of a device to persons with specific training or experience in its use or to persons for use in certain facilities unless the Secretary determines that such a restriction is required for the safe and effective use of the device. No such condition may exclude a person from using a device solely because the person does not have the training or experience to make him eligible for certification by a certifying board recognized by the American Board of Medical Specialties or has not been certified by such a Board. A device subject to a regulation under this subsection is a restricted device.
The Secretary shall provide the advisory committee a reasonable time to make its recommendation with respect to proposed regulations under subparagraph (A).
whichever occurs later, the Secretary shall by order either deny the petition or approve it.
An order of the Secretary approving a petition for a variance shall prescribe such conditions respecting the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of the device to be granted the variance under the petition as may be necessary to assure that the device will be safe and effective and otherwise in compliance with this chapter.
Members of the advisory committee who are not officers or employees of the United States, while attending conferences or meetings of the committee or otherwise engaged in its business, shall be entitled to receive compensation at rates to be fixed by the Secretary, which rates may not exceed the daily equivalent of the rate in effect for grade GS-18 of the General Schedule, for each day (including traveltime) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 for persons in the Government service employed intermittently. The Secretary shall designate one of the members of the advisory committee to serve as its chairman. The Secretary shall furnish the advisory committee with clerical and other assistance. Section 1013 of title 5 shall not apply with respect to the duration of the advisory committee established under this paragraph.
for review for adequacy to justify the commencement of such testing; and, unless the plan and report are submitted to the Secretary, submit to the Secretary a summary of the plan and a report of prior investigations of the device (including, where appropriate, tests on animals);
The determination required by subparagraph (D)(ii) shall be concurred in by a licensed physician who is not involved in the testing of the human subject with respect to which such determination is made unless immediate use of the device is required to save the life of the human subject of such testing and there is not sufficient time to obtain such concurrence.
shall be made available to the public upon issuance of the order. Summaries of information made available pursuant to this paragraph respecting a device shall include information respecting any adverse effects on health of the device.
Each panel under section 360c of this title and each advisory committee established under section 360d(b)(5)(B) or 360e(g) of this title or under subsection (f) of this section shall make and maintain a transcript of any proceeding of the panel or committee. Each such panel and committee shall delete from any transcript made pursuant to this subsection information which under subsection (c) of this section is to be considered confidential.
Except as provided in section 360i(e) of this title, no regulation under this chapter may impose on a type or class of device requirements for the traceability of such type or class of device unless such requirements are necessary to assure the protection of the public health.
The Secretary may enter into contracts for research, testing, and demonstrations respecting devices and may obtain devices for research, testing, and demonstration purposes without regard to section 3324(a) and (b) of title 31 and section 6101 of title 41.
is classified in class III unless the Secretary in response to a petition submitted under paragraph (2) has classified such device in class I or II.
within the sixty-day period beginning on the enactment date (or within such greater period as the Secretary, after making the finding required under section 360e(d)(1)(B) of this title, and the petitioner or applicant may agree upon), the Secretary shall act on such petition or application in accordance with paragraph (2) or section 360e of this title except that the period within which the Secretary must act on the petition or application shall be within the one hundred and twenty-day period beginning on the date the petition or application is filed. If such a petition or application is filed within such sixty-day (or greater) period, clause (i) of this subparagraph shall not apply to such device before the expiration of such one hundred and twenty-day period, or if such petition is denied or such application is denied approval, before the date of such denial, whichever occurs first.
If the requirements under subsection (g) of this section are made applicable to the investigational use of such a device, they shall be made applicable in such a manner that the device shall be made reasonably available to physicians meeting appropriate qualifications prescribed by the Secretary.
The request shall be in the form of an application submitted to the Secretary and such application shall include the certification required under section 282(j)(5)(B) of title 42 (which shall not be considered an element of such application). Not later than 75 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application.
In a case described in subparagraph (B) in which a physician uses a device without an approval from an institutional review committee or an appropriate local committee, the physician shall, after the use of the device, notify the chairperson of the institutional review committee or an appropriate local committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.
the Secretary shall not regulate the software function of such product described in subparagraph (A) as a device. Notwithstanding the preceding sentence, when assessing the safety and effectiveness of the device function or functions of such product described in subparagraph (B), the Secretary may assess the impact that the software function or functions described in subparagraph (A) have on such device function or functions.
The Secretary may, subject to the succeeding provisions of this subsection, approve an application (or a supplement to such an application) submitted under section 360e of this title with respect to an applicable medical imaging device, or, in the case of an applicable medical imaging device for which a notification is submitted under section 360(k) of this title, may make a substantial equivalence determination with respect to an applicable medical imaging device, or may grant a request submitted under section 360c(f)(2) of this title for an applicable medical imaging device, if such application, notification, or request involves the use of a contrast agent that is not-
The agency center charged with premarket review of devices shall have primary jurisdiction with respect to the review of an application, notification, or request described in paragraph (1). In conducting such review, such agency center may-
An application submitted under section 360e of this title, a notification submitted under section 360(k) of this title, or a request submitted under section 360c(f)(2) of this title, as described in paragraph (1), with respect to an applicable medical imaging device shall be subject to the requirements of such respective section. Such application, notification, or request shall only be subject to the requirements of this chapter applicable to devices.
For purposes of this subsection-
In this subsection, the term "over-the-counter hearing aid" means a device that-
Such term does not include a personal sound amplification product intended to amplify sound for nonhearing impaired consumers in situations including hunting and bird-watching.
An over-the-counter hearing aid shall be subject to the regulations promulgated in accordance with section 709(b) of the FDA Reauthorization Act of 2017 and shall be exempt from sections 801.420 and 801.421 of title 21, Code of Federal Regulations (or any successor regulations).
1See Delayed Applicability of Amendment note below.
2So in original. Probably should be "The term 'device',".
3So in original. Probably should be "sections".
21 U.S.C. § 360j
Delayed Applicability of Amendment For provisions related to delayed applicability of subsection (g)(9) of this section as added by section 3601(b) of Pub. L. 117-328 see Effective Date of 2022 Amendment note set out under section 355 of this title.
EDITORIAL NOTES
REFERENCES IN TEXTJuly 9, 2012, referred to in subsec. (b)(3), was in the original "the date of enactment of this section", which was translated as meaning the date of enactment of Pub. L. 112-144 which amended subsec. (b) generally, to reflect the probable intent of Congress.Section 709(b) of the FDA Reauthorization Act of 2017, referred to in subsec. (q)(2), is section 709(b) of Pub. L. 115-52 which is set out as a note below.
CODIFICATIONIn subsec. (k), "section 3324(a) and (b) of title 31 and section 6101 of title 41" substituted for "sections 3648 and 3709 of the Revised Statutes ( 31 U.S.C. 529, 41 U.S.C. 5)" on authority of Pub. L. 97-258, §4(b), Sept. 13, 1982, 96 Stat. 1067, which Act enacted Title 31, Money and Finance, and Pub. L. 111-350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
AMENDMENTS2022-Subsec. (f)(3). Pub. L. 117-286 substituted "Section 1013 of title 5" for "Section 14 of the Federal Advisory Committee Act" in concluding provisions. Subsec. (g)(9). Pub. L. 117-328, §3601(b), added par. (9). Subsec. (m)(6)(A)(iv). Pub. L. 117-328, §3103, substituted "October 1, 2027" for "December 24, 2022". Pub. L. 117-229 substituted "December 24, 2022" for "December 17, 2022". Pub. L. 117-180 substituted "December 17" for "October 1". 2017-Subsec. (m)(4). Pub. L. 115-52, §502(b)(1)(B), inserted "or an appropriate local committee" after "review committee" in two places in concluding provisions.Subsec. (m)(4)(B). Pub. L. 115-52, §502(b)(1)(A), inserted "or an appropriate local committee" after "review committee" in two places.Subsec. (m)(6)(A)(iv). Pub. L. 115-52, §502(b)(2), substituted "2022" for "2017". Subsec. (p). Pub. L. 115-52, §706(a), added subsec. (p).Subsec. (q). Pub. L. 115-52, §709(a), added subsec. (q). Amendment was executed to this section as amended by section 706(a) of Pub. L. 115-52 notwithstanding directory language referring to section as amended by section 708 of Pub. L. 115-52 which did not amend this section. 2016-Subsec. (g)(3). Pub. L. 114-255, §3024(a)(2), substituted "subparagraph (D)(ii)" for "subparagraph (D)" in concluding provisions.Subsec. (g)(3)(A)(i). Pub. L. 114-255, §3056(1)(A), struck out "local" before "institutional review committee" and "which has been" before "established in accordance with". Subsec. (g)(3)(B). Pub. L. 114-255, §3056(1)(B), substituted "an institutional" for "a local institutional".Subsec. (g)(3)(D). Pub. L. 114-255, §3024(a)(1), substituted "except where, subject to such conditions as the Secretary may prescribe-" for "except where subject to such conditions as the Secretary may prescribe,", added cl. (i), and inserted cl. (ii) designation before "the investigator". Subsec. (h)(4)(A). Pub. L. 114-255, §3038(b)(1), substituted "Subject to subparagraph (C), any information" for "Any information" in introductory provisions.Subsec. (h)(4)(C). Pub. L. 114-255, §3038(b)(2), added subpar. (C).Subsec. (m)(1). Pub. L. 114-255, §3052(a)(1), substituted "not more than 8,000" for "fewer than 4,000".Subsec. (m)(2)(A). Pub. L. 114-255, §3052(a)(2), substituted "not more than 8,000" for "fewer than 4,000". Subsec. (m)(4). Pub. L. 114-255, §3056(2)(C), struck out "local" after "chairperson of the" in concluding provisions.Subsec. (m)(4)(A). Pub. L. 114-255, §3056(2)(A), added subpar. (A) and struck out former subpar. (A) which read as follows: "in facilities that have established, in accordance with regulations of the Secretary, a local institutional review committee to supervise clinical testing of devices in the facilities, and".Subsec. (m)(4)(B). Pub. L. 114-255, §3056(2)(B), substituted "an institutional" for "a local institutional". Subsec. (m)(6)(A)(ii). Pub. L. 114-255, §3052(a)(3), substituted "8,000" for "4,000".Subsec. (o). Pub. L. 114-255, §3060(a), added subsec. (o).2012-Subsec. (b). Pub. L. 112-144, §617, amended subsec. (b) generally. Prior to amendment, subsec. (b) related to custom devices.Subsec. (g)(2)(B)(ii). Pub. L. 112-144, §601(1), inserted "safety or effectiveness" before "data obtained".Subsec. (g)(4)(C). Pub. L. 112-144, §601(2), added subpar. (C).Subsec. (g)(8). Pub. L. 112-144, §606, added par. (8).Subsec. (m)(6)(A)(i). Pub. L. 112-144, §613(a)(1)(A)(i), added cl. (i) and struck out former cl. (i) which read as follows:"(i)(I) The device with respect to which the exemption is granted is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs."(II) The device was not previously approved under this subsection for the pediatric patients or the pediatric subpopulation described in subclause (I) prior to September 27, 2007." Subsec. (m)(6)(A)(ii). Pub. L. 112-144, §613(a)(1)(A)(ii), added cl. (ii) and struck out former cl. (ii) which read as follows: "During any calendar year, the number of such devices distributed during that year does not exceed the annual distribution number specified by the Secretary when the Secretary grants such exemption. The annual distribution number shall be based on the number of individuals affected by the disease or condition that such device is intended to treat, diagnose, or cure, and of that number, the number of individuals likely to use the device, and the number of devices reasonably necessary to treat such individuals. In no case shall the annual distribution number exceed the number identified in paragraph (2)(A)." Subsec. (m)(6)(A)(iv). Pub. L. 112-144, §507(c), substituted "2017" for "2012".Subsec. (m)(6)(C). Pub. L. 112-144, §613(a)(1)(B), amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: "A person may petition the Secretary to modify the annual distribution number specified by the Secretary under subparagraph (A)(ii) with respect to a device if additional information on the number of individuals affected by the disease or condition arises, and the Secretary may modify such number but in no case shall the annual distribution number exceed the number identified in paragraph (2)(A)."Subsec. (m)(7). Pub. L. 112-144, §613(a)(2), substituted "regarding a device described in paragraph (6)(A)(i)(I)" for "regarding a device".Subsec. (m)(8). Pub. L. 112-144, §613(a)(3), substituted "of all devices described in paragraph (6)(A)(i)(I)" for "of all devices described in paragraph (6)".2007-Subsec. (m)(2). Pub. L. 110-85, §801(b)(3)(E), inserted before period at end of first sentence of concluding provisions "and such application shall include the certification required under section 282(j)(5)(B) of title 42 (which shall not be considered an element of such application)".Subsec. (m)(3). Pub. L. 110-85, §303(a)(1), substituted "Except as provided in paragraph (6), no" for "No".Subsec. (m)(5). Pub. L. 110-85, §303(a)(2), inserted ",if the Secretary has reason to believe that the requirements of paragraph (6) are no longer met," after "public health" and inserted at end "If the person granted an exemption under paragraph (2) fails to demonstrate continued compliance with the requirements of this subsection, the Secretary may suspend or withdraw the exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after providing notice and an opportunity for an informal hearing." Subsec. (m)(6) to (8). Pub. L. 110-85, §303(a)(3), added pars. (6) to (8) and struck out former par. (6) which read as follows: "The Secretary may suspend or withdraw an exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after providing notice and an opportunity for an informal hearing." 2005-Subsec. (n). Pub. L. 109-96 added subsec. (n).1997-Subsec. (f)(1)(B)(iii). Pub. L. 105-115, §410(a), added cl. (iii).Subsec. (g)(6), (7). Pub. L. 105-115, §201(a), added pars. (6) and (7). Subsec. (h)(4). Pub. L. 105-115, §216(a)(1), amended par. (4) generally. Prior to amendment, par. (4) related to premarket approval of devices.Subsec. (l). Pub. L. 105-115, §125(b)(2)(E), struck out "or antibiotic drugs" after "new drugs" in heading. Subsec. (l)(4). Pub. L. 105-115, §125(b)(2)(E), struck out par. (4) which read as follows: "Any device intended for human use which on the enactment date was subject to the requirements of section 357 of this title shall be subject to such requirements as follows:"(A) In the case of such a device which is classified into class I, such requirements shall apply to such device until the effective date of the regulation classifying the device into such class."(B) In the case of such a device which is classified into class II, such requirements shall apply to such device until the effective date of a performance standard applicable to the device under section 360d of this title."(C) In the case of such a device which is classified into class III, such requirements shall apply to such device until the date on which the device is required to have in effect an approved application under section 360e of this title." Subsec. (m)(2). Pub. L. 105-115, §203(1), inserted at end "The request shall be in the form of an application submitted to the Secretary. Not later than 75 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application." Subsec. (m)(4). Pub. L. 105-115, §203(2)(B), inserted at end "In a case described in subparagraph (B) in which a physician uses a device without an approval from an institutional review committee, the physician shall, after the use of the device, notify the chairperson of the local institutional review committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use."Subsec. (m)(4)(B). Pub. L. 105-115, §203(2)(A), inserted before period at end ",unless a physician determines in an emergency situation that approval from a local institutional review committee can not be obtained in time to prevent serious harm or death to a patient". Subsec. (m)(5). Pub. L. 105-115, §203(3), amended par. (5) generally. Prior to amendment, par. (5) read as follows: "An exemption under paragraph (2) shall be for a term of 18 months and may only be initially granted in the 5-year period beginning on the date regulations under paragraph (6) take effect. The Secretary may extend such an exemption for a period of 18 months if the Secretary is able to make the findings set forth in paragraph (2) and if the applicant supplies information demonstrating compliance with paragraph (3). An exemption may be extended more than once and may be extended after the expiration of such 5-year period."Subsec. (m)(6). Pub. L. 105-115, §203(4), amended par. (6) generally. Prior to amendment, par. (6) read as follows: "Within one year of November 28, 1990, the Secretary shall issue regulations to implement this subsection." 1992-Subsec. (g)(2)(A). Pub. L. 102-571 substituted "379e" for "376". 1990-Subsec. (c). Pub. L. 101-629, §11(1), substituted "from class III to class II or class I" for "under section 360c of this title from class III to class II" and inserted "(1) in accordance with subsection (h), and (2)" after "except". Subsec. (f)(1)(A). Pub. L. 101-629, §18(e), inserted "pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device)," after "manufacture,".Subsec. (h)(3). Pub. L. 101-629, §11(2)(A), substituted "Except as provided in paragraph (4), any" for "Any".Subsec. (h)(4). Pub. L. 101-629, §11(2)(B), added par. (4).Subsec. (i). Pub. L. 101-629, §6(b)(2), substituted "section 360d(b)(5)(B)" for "section 360d(g)(5)(B)". Subsec. (j). Pub. L. 101-629, §3(b)(2), substituted "Except as provided in section 360i(e) of this title, no" for "No". Subsec. (l)(2). Pub. L. 101-629, §18(f), struck out "and after affording the petitioner an opportunity for an informal hearing" after "under this paragraph". Pub. L. 101-629, §5(c)(2), substituted "The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer" for "The manufacturer". Subsec. (l)(5). Pub. L. 101-629, §4(b)(2), added par. (5). Subsec. (m). Pub. L. 101-629, §14(a), added subsec. (m).
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATE OF 2022 AMENDMENT Subsec. (g)(9) of this section, as added by section 3601(b) of Pub. L. 117-328 applicable only with respect to clinical investigations for which enrollment commences after the date that is 180 days after the publication of final guidance required under section 3602 of Pub. L. 117-328 see section 3602(c) of Pub. L. 117-328 set out as a note under section 355 of this title.
EFFECTIVE DATE OF 1997 AMENDMENT Amendment by sections 201(a), 203, 216(a)(1), and 410(a) 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 1990 AMENDMENT Pub. L. 101-629, §14(b), Nov. 28, 1990, 104 Stat. 4525, provided that: "Subsection (m) of section 520 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360j(m)], as added by the amendment made by subsection (a), shall take effect on the effective date of the regulations issued by the Secretary under paragraph (6) of such subsection."
REGULATIONS AND GUIDANCE CONCERNING OVER-THE-COUNTER HEARING AIDS Pub. L. 115-52, title VII, §709(b), (c), Aug. 18, 2017, 131 Stat. 1066, 1067, provided that: "(b) REGULATIONS TO ESTABLISH CATEGORY.- "(1) IN GENERAL.-The Secretary of Health and Human Services (referred to in this section [amending this section and enacting this note] as the 'Secretary'), not later than 3 years after the date of enactment of this Act [Aug. 18, 2017], shall promulgate proposed regulations to establish a category of over-the-counter hearing aids, as defined in subsection (q) of section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) as amended by subsection (a), and, not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations."(2) REQUIREMENTS.-In promulgating the regulations under paragraph (1), the Secretary shall-"(A) include requirements that provide reasonable assurances of the safety and effectiveness of over-the-counter hearing aids;"(B) include requirements that establish or adopt output limits appropriate for over-the-counter hearing aids;"(C) include requirements for appropriate labeling of over-the-counter hearing aids, including requirements that such labeling include a conspicuous statement that the device is only intended for adults age 18 and older, information on how consumers may report adverse events, information on any contraindications, conditions, or symptoms of medically treatable causes of hearing loss, and advisements to consult promptly with a licensed health care practitioner; and"(D) describe the requirements under which the sale of over-the-counter hearing aids is permitted, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online."(3) PREMARKET NOTIFICATION.-The Secretary shall make findings under section 510(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) to determine whether over-the-counter hearing aids (as defined in section 520(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j [(q)]), as amended by subsection (a)) require a report under section 510(k) [21 U.S.C. 360(k)] to provide reasonable assurance of safety and effectiveness."(4) EFFECT ON STATE LAW.-No State or local government shall establish or continue in effect any law, regulation, order, or other requirement specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of over-the-counter hearing aids (as defined in section 520(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j [(q)]), as amended by subsection (a)) through in-person transactions, by mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations promulgated under this subsection, including any State or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access over-the-counter hearing aids."(5) NO EFFECT ON PRIVATE REMEDIES.-Nothing in this section shall be construed to modify or otherwise affect the ability of any person to exercise a private right of action under any State or Federal product liability, tort, warranty, contract, or consumer protection law. "(c) NEW GUIDANCE ISSUED.-Not later than the date on which final regulations are issued under subsection (b), the Secretary shall update and finalize the draft guidance of the Department of Health and Human Services entitled 'Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products', issued on November 7, 2013. Such updated and finalized guidance shall clarify which products, on the basis of claims or other marketing, advertising, or labeling material, meet the definition of a device in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) and which products meet the definition of a personal sound amplification product, as set forth in such guidance."
GUIDANCE DOCUMENT ON PROBABLE BENEFIT Pub. L. 114-255, div. A, title III, §3052(b), Dec. 13, 2016, 130 Stat. 1125, provided that: "Not later than 18 months after the date of enactment of this Act [Dec. 13, 2016], the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance that defines the criteria for establishing 'probable benefit' as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)(C))."
REPORTS Pub. L. 114-255, div. A, title III, §3060(b), Dec. 13, 2016, 130 Stat. 1132, provided that: "The Secretary of Health and Human Services (referred to in this subsection as the 'Secretary'), after consultation with agencies and offices of the Department of Health and Human Services involved in health information technology, shall publish a report, not later than 2 years after the date of enactment of this Act [Dec. 13, 2016] and every 2 years thereafter, that-"(1) includes input from outside experts, such as representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant expertise, as determined by the Secretary;"(2) examines information available to the Secretary on any risks and benefits to health associated with software functions described in section 520(o)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j [(o)(1)]) (as amended by subsection (a)); and"(3) summarizes findings regarding the impact of such software functions on patient safety, including best practices to promote safety, education, and competency related to such functions."
APPLICABILITY TO EXISTING DEVICES Pub. L. 112-144, title VI, §613(b), July 9, 2012, 126 Stat. 1061, provided that: "A sponsor of a device for which an exemption was approved under paragraph (2) of section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) before the date of enactment of this Act [July 9, 2012] may seek a determination under subclause (I) or (II) of section 520(m)(6)(A)(i) (as amended by subsection (a)). If the Secretary of Health and Human Services determines that such subclause (I) or (II) applies with respect to a device, clauses (ii), (iii), and (iv) of subparagraph (A) and subparagraphs (B), (C), (D), and (E) of paragraph (6) of such section 520(m) shall apply to such device, and the Secretary shall determine the annual distribution number for purposes of clause (ii) of such subparagraph (A) when making the determination under this subsection."
GUIDANCE Pub. L. 110-85, title III, §303(c), Sept. 27, 2007, 121 Stat. 862, provided that: "Not later than 180 days after the date of the enactment of this Act [Sept. 27, 2007], the Commissioner of Food and Drugs shall issue guidance for institutional review committees on how to evaluate requests for approval for devices for which a humanitarian device exemption under section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted." Pub. L. 107-250, title II, §213, Oct. 26, 2002, 116 Stat. 1614, provided that: "Not later than 270 days after the date of the enactment of this Act [Oct. 26, 2002], the Secretary of Health and Human Services shall issue guidance on the following:"(1) The type of information necessary to provide reasonable assurance of the safety and effectiveness of medical devices intended for use in pediatric populations. "(2) Protections for pediatric subjects in clinical investigations of the safety or effectiveness of such devices."
REPORT ON HUMANITARIAN DEVICE EXEMPTIONS Pub. L. 101-629, §14(c), Nov. 28, 1990, 104 Stat. 4525, directed Secretary of Health and Human Services, within 4 years after issuance of regulations under 21 U.S.C. 360j(m)(6), to report to Congress on types of devices exempted, an evaluation of effects of such section, and a recommendation on extension of the section.
REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATESReferences in laws to the rates of pay for GS-16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of Pub. L. 101-509 set out in a note under section 5376 of Title 5.