21 U.S.C. § 360d — Performance standards

Page 344 TITLE 21—FOOD AND DRUGS § 360d Editorial Notes CODIFICATION Section was enacted as part of the Food and Drug Ad- ministration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter. § 360d. Performance standards (a) Reasonable assurance of safe and effective performance; periodic evaluation (1) The special controls required by section 360c(a)(1)(B) of this title shall include perform- ance standards for a class II device if the Sec- retary determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device. A class III device may also be considered a class II device for purposes of establishing a standard for the device under subsection (b) if the device has been reclassified as a class II device under an administrative order under section 360c(e) of this title (or a regulation promulgated under such section prior to July 9, 2012) but such order (or regulation) provides that the reclassification is not to take effect until the effective date of such a standard for the device. (2) A performance standard established under subsection (b) for a device— (A) shall include provisions to provide rea- sonable assurance of its safe and effective per- formance; (B) shall, where necessary to provide reason- able assurance of its safe and effective per- formance, include— (i) provisions respecting the construction, components, ingredients, and properties of the device and its compatibility with power systems and connections to such systems, (ii) provisions for the testing (on a sample basis or, if necessary, on an individual basis) of the device or, if it is determined that no other more practicable means are available to the Secretary to assure the conformity of the device to the standard, provisions for the testing (on a sample basis or, if necessary, on an individual basis) by the Secretary or by another person at the direction of the Secretary, (iii) provisions for the measurement of the performance characteristics of the device, (iv) provisions requiring that the results of each or of certain of the tests of the device required to be made under clause (ii) show that the device is in conformity with the portions of the standard for which the test or tests were required, and (v) a provision requiring that the sale and distribution of the device be restricted but only to the extent that the sale and distribu- tion of a device may be restricted under a regulation under section 360j(e) of this title; and (C) shall, where appropriate, require the use and prescribe the form and content of labeling for the proper installation, maintenance, oper- ation, and use of the device. (3) The Secretary shall provide for periodic evaluation of performance standards established under subsection (b) to determine if such stand- ards should be changed to reflect new medical, scientific, or other technological data. (4) In carrying out his duties under this sub- section and subsection (b), the Secretary shall, to the maximum extent practicable— (A) use personnel, facilities, and other tech- nical support available in other Federal agen- cies, (B) consult with other Federal agencies con- cerned with standard-setting and other nation- ally or internationally recognized standard- setting entities, and (C) invite appropriate participation, through joint or other conferences, workshops, or other means, by informed persons representative of scientific, professional, industry, or consumer organizations who in his judgment can make a significant contribution. (b) Establishment of a standard (1)(A) The Secretary shall publish in the Fed- eral Register a notice of proposed rulemaking for the establishment, amendment, or revoca- tion of any performance standard for a device. (B) A notice of proposed rulemaking for the es- tablishment or amendment of a performance standard for a device shall— (i) set forth a finding with supporting jus- tification that the performance standard is ap- propriate and necessary to provide reasonable assurance of the safety and effectiveness of the device, (ii) set forth proposed findings with respect to the risk of illness or injury that the per- formance standard is intended to reduce or eliminate, (iii) invite interested persons to submit to the Secretary, within 30 days of the publica- tion of the notice, requests for changes in the classification of the device pursuant to section 360c(e) of this title based on new information relevant to the classification, and (iv) invite interested persons to submit an existing performance standard for the device, including a draft or proposed performance standard, for consideration by the Secretary. (C) A notice of proposed rulemaking for the revocation of a performance standard shall set forth a finding with supporting justification that the performance standard is no longer nec- essary to provide reasonable assurance of the safety and effectiveness of a device. (D) The Secretary shall provide for a comment period of not less than 60 days. (2) If, after publication of a notice in accord- ance with paragraph (1), the Secretary receives a request for a change in the classification of the device, the Secretary shall, within 60 days of the publication of the notice, after consultation with the appropriate panel under section 360c of this title, either deny the request or give notice of an intent to initiate such change under sec- tion 360c(e) of this title. (3)(A) After the expiration of the period for comment on a notice of proposed rulemaking published under paragraph (1) respecting a per- formance standard and after consideration of such comments and any report from an advisory committee under paragraph (5), the Secretary shall (i) promulgate a regulation establishing a performance standard and publish in the Federal Page 345 TITLE 21—FOOD AND DRUGS § 360d Register findings on the matters referred to in paragraph (1), or (ii) publish a notice termi- nating the proceeding for the development of the standard together with the reasons for such termination. If a notice of termination is pub- lished, the Secretary shall (unless such notice is issued because the device is a banned device under section 360f of this title) initiate a pro- ceeding under section 360c(e) of this title to re- classify the device subject to the proceeding ter- minated by such notice. (B) A regulation establishing a performance standard shall set forth the date or dates upon which the standard shall take effect, but no such regulation may take effect before one year after the date of its publication unless (i) the Sec- retary determines that an earlier effective date is necessary for the protection of the public health and safety, or (ii) such standard has been established for a device which, effective upon the effective date of the standard, has been re- classified from class III to class II. Such date or dates shall be established so as to minimize, consistent with the public health and safety, economic loss to, and disruption or dislocation of, domestic and international trade. (4)(A) The Secretary, upon his own initiative or upon petition of an interested person may by regulation, promulgated in accordance with the requirements of paragraphs (1), (2), and (3)(B) of this subsection, amend or revoke a performance standard. (B) The Secretary may declare a proposed amendment of a performance standard to be ef- fective on and after its publication in the Fed- eral Register and until the effective date of any final action taken on such amendment if he de- termines that making it so effective is in the public interest. A proposed amendment of a per- formance standard made so effective under the preceding sentence may not prohibit, during the period in which it is so effective, the introduc- tion or delivery for introduction into interstate commerce of a device which conforms to such standard without the change or changes pro- vided by such proposed amendment. (5)(A) The Secretary— (i) may on his own initiative refer a pro- posed regulation for the establishment, amendment, or revocation of a performance standard, or (ii) shall, upon the request of an interested person which demonstrates good cause for re- ferral and which is made before the expiration of the period for submission of comments on such proposed regulation refer such proposed regulation, to an advisory committee of experts, established pursuant to subparagraph (B), for a report and recommendation with respect to any matter in- volved in the proposed regulation which requires the exercise of scientific judgment. If a proposed regulation is referred under this subparagraph to an advisory committee, the Secretary shall provide the advisory committee with the data and information on which such proposed regula- tion is based. The advisory committee shall, within sixty days of the referral of a proposed regulation and after independent study of the data and information furnished to it by the Sec- retary and other data and information before it, submit to the Secretary a report and rec- ommendation respecting such regulation, to- gether with all underlying data and information and a statement of the reason or basis for the recommendation. A copy of such report and rec- ommendation shall be made public by the Sec- retary. (B) The Secretary shall establish advisory committees (which may not be panels under sec- tion 360c of this title) to receive referrals under subparagraph (A). The Secretary shall appoint as members of any such advisory committee per- sons qualified in the subject matter to be re- ferred to the committee and of appropriately di- versified professional background, except that the Secretary may not appoint to such a com- mittee any individual who is in the regular full- time employ of the United States and engaged in the administration of this chapter. Each such committee shall include as nonvoting members a representative of consumer interests and a representative of interests of the device manu- facturing industry. Members of an advisory committee who are not officers or employees of the United States, while attending conferences or meetings of their committee or otherwise serving at the request of the Secretary, shall be entitled to receive compensation at rates to be fixed by the Secretary, which rates may not ex- ceed 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 each advisory committee to serve as chairman thereof. The Secretary shall furnish each advisory committee with clerical and other assistance, and shall by regulation prescribe the procedures to be fol- lowed by each such committee in acting on re- ferrals made under subparagraph (A). (c) Recognition of standard (1)(A) In addition to establishing a perform- ance standard under this section, the Secretary shall, by publication in the Federal Register (or, with respect to a susceptibility test interpretive criteria standard under section 360a–2 of this title, by posting on the Interpretive Criteria Website in accordance with such section), recog- nize all or part of an appropriate standard estab- lished by a nationally or internationally recog- nized standard development organization for which a person may submit a declaration of con- formity in order to meet a premarket submis- sion requirement or other requirement under this chapter to which such standard is applica- ble. (B) If a person elects to use a standard recog- nized by the Secretary under subparagraph (A) to meet the requirements described in such sub- paragraph, the person shall provide a declara- tion of conformity to the Secretary that cer- tifies that the device is in conformity with such standard. A person may elect to use data, or in- formation, other than data required by a stand- ard recognized under subparagraph (A) to meet Page 346 TITLE 21—FOOD AND DRUGS § 360d 1 So in original. Probably should be ‘‘standard development or- ganization.’’ any requirement regarding devices under this chapter. (C)(i) Any person may submit a request for recognition under subparagraph (A) of all or part of an appropriate standard established by a nationally or internationally recognized stand- ard organization.1 (ii) Not later than 60 calendar days after the Secretary receives such a request, the Secretary shall— (I) make a determination to recognize all, part, or none of the standard that is the sub- ject of the request; and (II) issue to the person who submitted such request a response in writing that states the Secretary’s rationale for that determination, including the scientific, technical, regulatory, or other basis for such determination. (iii) The Secretary shall make a response issued under clause (ii)(II) publicly available, in such a manner as the Secretary determines ap- propriate. (iv) The Secretary shall take such actions as may be necessary to implement all or part of a standard recognized under clause (ii)(I), in ac- cordance with subparagraph (A). (D) The Secretary shall make publicly avail- able, in such manner as the Secretary deter- mines appropriate, the rationale for recognition under subparagraph (A) of all, part, or none of a standard, including the scientific, technical, regulatory, or other basis for the decision re- garding such recognition. (2) The Secretary may withdraw such recogni- tion of a standard through publication of a no- tice in the Federal Register if the Secretary de- termines that the standard is no longer appro- priate for meeting a requirement regarding de- vices under this chapter. (3)(A) Subject to subparagraph (B), the Sec- retary shall accept a declaration of conformity that a device is in conformity with a standard recognized under paragraph (1) unless the Sec- retary finds— (i) that the data or information submitted to support such declaration does not demonstrate that the device is in conformity with the standard identified in the declaration of con- formity; or (ii) that the standard identified in the dec- laration of conformity is not applicable to the particular device under review. (B) The Secretary may request, at any time, the data or information relied on by the person to make a declaration of conformity with re- spect to a standard recognized under paragraph (1). (C) A person making a declaration of con- formity with respect to a standard recognized under paragraph (1) shall maintain the data and information demonstrating conformity of the device to the standard for a period of two years after the date of the classification or approval of the device by the Secretary or a period equal to the expected design life of the device, whichever is longer. (4) The Secretary shall provide to all employ- ees of the Food and Drug Administration who review premarket submissions for devices peri- odic training on the concept and use of recog- nized standards for purposes of meeting a pre- market submission requirement or other appli- cable requirement under this chapter, including standards relevant to an employee’s area of de- vice review. (d) Accreditation scheme for conformity assess- ment (1) In general The Secretary shall establish a program under which— (A) testing laboratories meeting criteria specified in guidance by the Secretary may be accredited, by accreditation bodies meet- ing criteria specified in guidance by the Sec- retary, to conduct testing to support the as- sessment of the conformity of a device to certain standards recognized under this sec- tion; and (B) subject to paragraph (2), results from tests conducted to support the assessment of conformity of devices as described in sub- paragraph (A) conducted by testing labora- tories accredited pursuant to this subsection shall be accepted by the Secretary for pur- poses of demonstrating such conformity un- less the Secretary finds that certain results of such tests should not be so accepted. (2) Secretarial review of accredited laboratory results The Secretary may— (A) review the results of tests conducted by testing laboratories accredited pursuant to this subsection, including by conducting periodic audits of such results or of the proc- esses of accredited bodies or testing labora- tories; (B) following such review, take additional measures under this chapter, as the Sec- retary determines appropriate, such as— (i) suspension or withdrawal of accredi- tation of a testing laboratory or recogni- tion of an accreditation body under para- graph (1)(A); or (ii) requesting additional information with respect to a device; and (C) if the Secretary becomes aware of in- formation materially bearing on the safety or effectiveness of a device for which an as- sessment of conformity was supported by testing conducted by a testing laboratory accredited under this subsection, take such additional measures under this chapter, as the Secretary determines appropriate, such as— (i) suspension or withdrawal of accredi- tation of a testing laboratory or recogni- tion of an accreditation body under para- graph (1)(A); or (ii) requesting additional information with regard to such device. (3) Report The Secretary shall make available on the internet website of the Food and Drug Admin- istration an annual report on the progress of the program under this subsection. (June 25, 1938, ch. 675, § 514, as added Pub. L. 94–295, § 2, May 28, 1976, 90 Stat. 546; amended Page 347 TITLE 21—FOOD AND DRUGS § 360d Pub. L. 94–460, title III, § 304, Oct. 8, 1976, 90 Stat. 1960; Pub. L. 101–629, §§ 6(a), (b)(1), 18(b), Nov. 28, 1990, 104 Stat. 4519, 4528; Pub. L. 102–300, § 6(g), June 16, 1992, 106 Stat. 241; Pub. L. 103–80, § 4(a)(1), Aug. 13, 1993, 107 Stat. 779; Pub. L. 105–115, title II, § 204(a), (d), Nov. 21, 1997, 111 Stat. 2335, 2336; Pub. L. 112–144, title VI, § 608(a)(2)(B), July 9, 2012, 126 Stat. 1056; Pub. L. 114–255, div. A, title III, §§ 3044(b)(3), 3053(a), Dec. 13, 2016, 130 Stat. 1121, 1125; Pub. L. 115–52, title II, § 205(a), Aug. 18, 2017, 131 Stat. 1016; Pub. L. 117–180, div. F, title II, § 2005, Sept. 30, 2022, 136 Stat. 2153.) Editorial Notes AMENDMENTS 2022—Subsec. (d). Pub. L. 117–180 amended subsec. (d) generally. Prior to amendment, subsec. (d) related to a pilot program for accrediting laboratories to assess de- vice conformance. 2017—Subsec. (d). Pub. L. 115–52 added subsec. (d). 2016—Subsec. (c)(1)(A). Pub. L. 114–255, § 3044(b)(3), in- serted ‘‘(or, with respect to a susceptibility test inter- pretive criteria standard under section 360a–2 of this title, by posting on the Interpretive Criteria Website in accordance with such section)’’ after ‘‘the Secretary shall, by publication in the Federal Register’’. Subsec. (c)(1)(C), (D). Pub. L. 114–255, § 3053(a)(1), added subpars. (C) and (D). Subsec. (c)(4). Pub. L. 114–255, § 3053(a)(2), added par. (4). 2012—Subsec. (a)(1). Pub. L. 112–144 substituted ‘‘under an administrative order under section 360c(e) of this title (or a regulation promulgated under such sec- tion prior to July 9, 2012) but such order (or regula- tion)’’ for ‘‘under a regulation under section 360c(e) of this title but such regulation’’. 1997—Subsec. (a)(1). Pub. L. 105–115, § 204(d)(1), sub- stituted ‘‘under subsection (b)’’ for ‘‘under this sec- tion’’. Subsec. (a)(2). Pub. L. 105–115, § 204(d)(2), substituted ‘‘under subsection (b)’’ for ‘‘under this section’’ in in- troductory provisions. Subsec. (a)(3). Pub. L. 105–115, § 204(d)(3), substituted ‘‘under subsection (b)’’ for ‘‘under this section’’. Subsec. (a)(4). Pub. L. 105–115, § 204(d)(4), substituted ‘‘this subsection and subsection (b)’’ for ‘‘this section’’ in introductory provisions. Subsec. (c). Pub. L. 105–115, § 204(a), added subsec. (c). 1993—Subsec. (b)(4)(B), (5)(A)(ii). Pub. L. 103–80 amended directory language of Pub. L. 101–619, § 18(b), identical to amendment by Pub. L. 102–300, § 6(g)(1). See 1992 and 1990 Amendment notes below. 1992—Subsec. (b)(4)(B), (5)(A)(ii). Pub. L. 102–300 made technical corrections to directory language of Pub. L. 101–629, § 18(b)(1), (2). See 1990 Amendment note below. 1990—Subsec. (a)(1). Pub. L. 101–629, § 6(a)(1), sub- stituted ‘‘The special controls required by section 360c(a)(1)(B) of this title shall include performance standards for a class II device if the Secretary deter- mines that a performance standard is necessary to pro- vide reasonable assurance of the safety and effective- ness of the device.’’ for ‘‘The Secretary may by regula- tion, promulgated in accordance with this section, es- tablish a performance standard for a class II device.’’ Subsec. (b). Pub. L. 101–629, § 6(a)(2), (3), redesignated subsec. (g) as (b) and struck out former subsec. (b) which read as follows: ‘‘(1) A proceeding for the development of a perform- ance standard for a device shall be initiated by the Sec- retary by the publication in the Federal Register of no- tice of the opportunity to submit to the Secretary a re- quest (within fifteen days of the date of the publication of the notice) for a change in the classification of the device based on new information relevant to its classi- fication. ‘‘(2) If, after publication of a notice pursuant to para- graph (1) the Secretary receives a request for a change in the device’s classification, he shall, within sixty days of the publication of such notice and after con- sultation with the appropriate panel under section 360c of this title, by order published in the Federal Register, either deny the request for change in classification or give notice of his intent to initiate such a change under section 360c(e) of this title.’’ Subsec. (b)(1), (2). Pub. L. 101–629, § 6(a)(4), amended pars. (1) and (2) generally. Prior to amendment, pars. (1) and (2) read as follows: ‘‘(1)(A) After publication pursuant to subsection (c) of this section of a notice respecting a performance stand- ard for a device, the Secretary shall either— ‘‘(i) publish, in the Federal Register in a notice of proposed rulemaking, a proposed performance stand- ard for the device (I) developed by an offeror under such notice and accepted by the Secretary, (II) devel- oped under subsection (c)(4) of this section, (III) ac- cepted by the Secretary under subsection (d) of this section, or (IV) developed by him under subsection (f) of this section, or ‘‘(ii) issue a notice in the Federal Register that the proceeding is terminated together with the reasons for such termination. ‘‘(B) If the Secretary issues under subparagraph (A)(ii) a notice of termination of a proceeding to estab- lish a performance standard for a device, he shall (un- less such notice is issued because the device is a banned device under section 360f of this title) initiate a pro- ceeding under section 360c(e) of this title to reclassify the device subject to the proceeding terminated by such notice. ‘‘(2) A notice of proposed rulemaking for the estab- lishment of a performance standard for a device pub- lished under paragraph (1)(A)(i) shall set forth proposed findings with respect to the degree of the risk of illness or injury designed to be eliminated or reduced by the proposed standard and the benefit to the public from the device.’’ Subsec. (b)(3)(A)(i). Pub. L. 101–629, § 6(b)(1)(A), sub- stituted ‘‘paragraph (1)’’ for ‘‘paragraph (2)’’. Subsec. (b)(4)(A). Pub. L. 101–629, § 6(b)(1)(B), sub- stituted ‘‘paragraphs (1), (2), and (3)(B)’’ for ‘‘para- graphs (2) and (3)(B)’’. Subsec. (b)(4)(B). Pub. L. 101–629, § 18(b)(1), as amend- ed by Pub. L. 102–300, § 6(g)(1), (2), and Pub. L. 103–80, § 4(a)(1), struck out ‘‘, after affording all interested per- sons an opportunity for an informal hearing,’’ after ‘‘if he determines’’. Subsec. (b)(5)(A)(ii). Pub. L. 101–629, § 18(b)(2), as amended by Pub. L. 102–300, § 6(g)(1), (3), and Pub. L. 103–80, § 4(a)(1), substituted ‘‘which demonstrates good cause for referral and which is made before the expira- tion of the period for submission of comments on such proposed regulation refer such proposed regulation,’’ for ‘‘unless the Secretary finds the request to be with- out good cause or the request is made after the expira- tion of the period for submission of comments on such proposed regulation refer such proposed regulation,’’. Subsecs. (c) to (f). Pub. L. 101–629, § 6(a)(2), struck out subsec. (c) relating to invitations for standards, subsec. (d) relating to acceptance of certain existing standards, subsec. (e) relating to acceptance of offers to develop standards, and subsec. (f) relating to development of standards by the Secretary after publication of notice inviting submissions or offers of standards. Subsec. (g). Pub. L. 101–629, § 6(a)(3), redesignated sub- sec. (g) as (b). 1976—Subsec. (a). Pub. L. 94–460 redesignated pars. (4) and (5) as (3) and (4), respectively. Section as originally enacted contained no par. (3). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2022 AMENDMENT Pub. L. 117–180, div. F, title II, § 2008, Sept. 30, 2022, 136 Stat. 2154, provided that: ‘‘The amendments made by this title [amending this section and sections 360m and 379i to 379j–1 of this title and repealing provisions set Page 348 TITLE 21—FOOD AND DRUGS § 360e out as notes under sections 379i and 379j–1 of this title] shall take effect on October 1, 2022, or the date of the enactment of this Act [Sept. 30, 2022], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.) shall be assessed for all sub- missions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] received on or after October 1, 2022, regardless of the date of the enactment of this Act.’’ EFFECTIVE DATE OF 2017 AMENDMENT Amendment by Pub. L. 115–52 effective Oct. 1, 2017, with fees under subpart 3 of part C of subchapter VII of this chapter to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title. EFFECTIVE DATE OF 1997 AMENDMENT Amendment by 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. CONSTRUCTION OF 2016 AMENDMENT Nothing in amendment by section 3044(b)(3) of Pub. L. 114–255 to be construed to restrict the prescribing of antimicrobial drugs or other products, including drugs approved under section 356(h) of this title, by health care professionals, or to limit the practice of health care, see section 3043 of Pub. L. 114–255, set out as a note under section 356 of this title. TERMINATION OF ADVISORY COMMITTEES Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, and advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2- year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 1013 of Title 5, Government Organization and Employees. GUIDANCE Pub. L. 114–255, div. A, title III, § 3053(b), Dec. 13, 2016, 130 Stat. 1125, provided that: ‘‘The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall review and update, if nec- essary, previously published guidance and standard op- erating procedures identifying the principles for recog- nizing standards, and for withdrawing the recognition of standards, under section 514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)), taking into account the experience with and reliance on a standard by foreign regulatory authorities and the device indus- try, and whether recognition of a standard will pro- mote harmonization among regulatory authorities in the regulation of devices.’’ REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY RATES References 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 Organi- zation 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. § 360e. Premarket approval (a) General requirement A class III device— (1) which is subject to an order issued under subsection (b) (or a regulation promulgated under such subsection prior to July 9, 2012); or (2) which is a class III device because of sec- tion 360c(f) of this title, is required to have, unless exempt under section 360j(g) of this title, an approval under this sec- tion of an application for premarket approval or, as applicable, an approval under subsection (c)(2) of a report seeking premarket approval. (b) Order to require premarket approval (1) In the case of a class III device which— (A) was introduced or delivered for introduc- tion into interstate commerce for commercial distribution before May 28, 1976; or (B) is (i) of a type so introduced or delivered, and (ii) is substantially equivalent to another device within that type, the Secretary shall by administrative order fol- lowing publication of a proposed order in the Federal Register, a meeting of a device classi- fication panel described in section 360c(b) of this title, and consideration of comments from all af- fected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5, require that such device have an approval under this section of an appli- cation for premarket approval. Authority to issue such administrative order shall not be del- egated below the Director of the Center for De- vices and Radiological Health, acting in con- sultation with the Commissioner. (2) A proposed order required under paragraph (1) shall contain— (A) the proposed order; (B) proposed findings with respect to the de- gree of risk of illness or injury designed to be eliminated or reduced by requiring the device to have an approved application for premarket approval and the benefit to the public from use of the device; (C) opportunity for the submission of com- ments on the proposed order and the proposed findings; and (D) opportunity to request a change in the classification of the device based on new infor- mation relevant to the classification of the de- vice. (3) After the expiration of the period for com- ment on a proposed order and proposed findings published under paragraph (2), consideration of comments submitted on such proposed order and findings, and a meeting of a device classification panel described in section 360c(b) of this title, the Secretary shall (A) issue an administrative order under paragraph (1) and publish in the Federal Register findings on the matters re- ferred to in paragraph (2)(B), or (B) publish a no- tice terminating the proceeding for the issuance of the administrative order together with the reasons for such termination. If a notice of ter- mination is published, the Secretary shall (un- less such notice is issued because the device is a banned device under section 360f of this title) initiate a proceeding under section 360c(e) of this title to reclassify the device subject to the proceeding terminated by such notice. (c) Application for premarket approval (1) Any person may file with the Secretary an application for premarket approval for a class