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

submitted 88 years ago by Pub. L. 94-295 to r/title-21-FOOD-AND-DRUGS · 2,655 words · no verdicts yet

in plain englishAI-generated · not legal advice

This law lets the FDA set safety performance standards for medical devices. It explains how the FDA creates, changes, or cancels a standard, and how it can recognize outside standards instead. It also sets up a system for accrediting testing labs.

(a) Reasonable assurance of safe and effective performance; periodic evaluation (1) The special controls required for a class II device must include a performance standard when the Secretary decides a standard is needed to reasonably assure the device is safe and effective. A class III device can be treated as class II for standard-setting purposes if it was reclassified to class II under an order (or an older regulation) that said the reclassification only takes effect once a standard for the device takes effect. (2) A performance standard set under subsection (b) must: (A) include provisions that give reasonable assurance of safe and effective performance; (B) where needed for that assurance, include rules about (i) the device's construction, components, ingredients, properties, and compatibility with power systems, (ii) testing the device — by sample, or individually if necessary — including testing by the Secretary or someone the Secretary directs, if that's the only practical way to check compliance, (iii) how to measure the device's performance, (iv) a requirement that test results actually show the device meets the standard, and (v) a rule allowing the device's sale and distribution to be restricted, but only as far as section 360j(e) allows; and (C) where appropriate, require specific labeling for properly installing, maintaining, operating, and using the device. (3) The Secretary must periodically review standards to see if new medical, scientific, or technical information means they should be changed. (4) In doing this work, the Secretary must, as much as practical: (A) use staff, facilities, and technical support from other federal agencies, (B) consult with other federal agencies and with nationally or internationally recognized standard-setting groups, and (C) invite scientific, professional, industry, or consumer experts to contribute, through conferences, workshops, or other means. (b) Establishing a standard (1)(A) The Secretary must publish a notice in the Federal Register proposing to create, change, or cancel a device performance standard. (B) A notice proposing to create or change a standard must: (i) explain, with support, why the standard is appropriate and necessary for the device's safety and effectiveness, (ii) propose findings about the illness or injury risk the standard is meant to reduce, (iii) invite people to ask, within 30 days, for the device's classification to be changed based on new information, and (iv) invite people to submit an existing or draft standard for the Secretary to consider. (C) A notice proposing to cancel a standard must explain, with support, why the standard is no longer needed for the device's safety and effectiveness. (D) The public must get at least 60 days to comment. (2) If someone asks for a reclassification after the notice is published, the Secretary must, within 60 days and after consulting the relevant advisory panel, either deny the request or announce plans to start the reclassification process. (3)(A) After the comment period ends, and after considering the comments and any advisory-committee report, the Secretary must either (i) issue a regulation creating the standard and publish the required findings, or (ii) publish a notice ending the process, with reasons. If the process ends and the device isn't a banned device, the Secretary must start a proceeding to reclassify it. (B) A regulation setting a standard must state when it takes effect. It generally cannot take effect sooner than one year after publication, unless the Secretary decides an earlier date is needed to protect public health and safety, or the standard applies to a device that was just reclassified from class III to class II effective the same date. The effective date should be set to limit economic loss and trade disruption as much as possible while still protecting public health and safety. (4)(A) The Secretary, on his own initiative or on a petition, may amend or revoke a standard by following the same steps required in paragraphs (1), (2), and (3)(B). (B) The Secretary can make a proposed amendment effective right when it's published, if that serves the public interest, until final action is taken on it. While it's in effect this way, it cannot be used to block a device that already meets the standard without the proposed change from entering interstate commerce. (5)(A) The Secretary may, on his own initiative, or must, if someone shows good cause and asks before the comment period ends, send a proposed standard regulation to an advisory committee for a report and recommendation on any scientific-judgment question it raises. The Secretary must give the committee the underlying data. Within 60 days, the committee must study it and report back to the Secretary with its recommendation, the underlying data, and its reasoning. The Secretary must make that report public. (B) The Secretary must set up these advisory committees separately from the panels under section 360c. Members must be qualified in the subject and have varied professional backgrounds; the Secretary cannot appoint anyone who is a full-time federal employee administering this law. Each committee must include a nonvoting consumer representative and a nonvoting device-industry representative. Non-federal members can be paid, capped at the daily rate for GS–18, and get travel expenses. The Secretary names a chairperson, provides staff support, and sets each committee's procedures by regulation. (c) Recognizing outside standards (1)(A) Besides setting its own standards, the Secretary must publish in the Federal Register (or, for certain lab-test standards, post on the Interpretive Criteria Website) recognition of all or part of a standard from a nationally or internationally recognized standards organization, so people can use it to meet a requirement under this law. (B) A person using a recognized standard must give the Secretary a “declaration of conformity” certifying the device meets that standard. A person may instead use other data to meet a device requirement, rather than the data a recognized standard calls for. (C)(i) Anyone can ask the Secretary to recognize all or part of such an outside standard. (ii) Within 60 calendar days, the Secretary must decide whether to recognize all, part, or none of it, and must give the requester a written response explaining the scientific, technical, regulatory, or other basis for that decision. (iii) The Secretary must make that response public. (iv) The Secretary must take the steps needed to put any recognized part of the standard into practice. (D) The Secretary must publicly explain the basis for recognizing — or not recognizing — all, part, or none of a standard. (2) The Secretary can withdraw recognition of a standard, by publishing a notice in the Federal Register, if it's no longer appropriate for meeting a device requirement. (3)(A) The Secretary must accept a declaration of conformity with a recognized standard unless the Secretary finds (i) the supporting data doesn't actually show the device conforms to the standard named, or (ii) that standard doesn't apply to the particular device. (B) The Secretary can ask, at any time, for the data behind a declaration of conformity. (C) A person making such a declaration must keep the supporting data for two years after the device is classified or approved, or for the device's expected design life, whichever is longer. (4) The Secretary must give FDA employees who review device submissions periodic training on using recognized standards, including the standards relevant to each employee's own review area. (d) Accreditation system for outside testing (1) The Secretary must set up a program where: (A) testing labs that meet FDA guidance criteria can be accredited, by accreditation bodies that also meet FDA guidance criteria, to test whether a device conforms to certain recognized standards; and (B) subject to paragraph (2), the Secretary must accept results from tests done by these accredited labs as proof of conformity, unless the Secretary finds certain results should not be accepted. (2) The Secretary may: (A) review the results of tests done by accredited labs, including through periodic audits of the results or of the labs' or accreditation bodies' processes; (B) after that review, take appropriate action, such as suspending or withdrawing a lab's accreditation or a body's recognition, or asking for more information about a device; and (C) if the Secretary learns of information that matters to a device's safety or effectiveness, take similar appropriate action — suspending or withdrawing accreditation or recognition, or requesting more information about that device. (3) The Secretary must publish an annual report on the FDA's website tracking this accreditation program's progress.

the actual law source: uscode.house.gov ↗public domain

(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 performance standards for a class II device if the Secretary 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 reasonable assurance of its safe and effective performance;

(B)

shall, where necessary to provide reasonable assurance of its safe and effective performance, 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 distribution 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, operation, and use of the device.

(3)

The Secretary shall provide for periodic evaluation of performance standards established under subsection (b) to determine if such standards should be changed to reflect new medical, scientific, or other technological data.

(4)

In carrying out his duties under this subsection and subsection (b), the Secretary shall, to the maximum extent practicable—

(A)

use personnel, facilities, and other technical support available in other Federal agencies,

(B)

consult with other Federal agencies concerned with standard-setting and other nationally 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 Federal Register a notice of proposed rulemaking for the establishment, amendment, or revocation of any performance standard for a device.

(B)

A notice of proposed rulemaking for the establishment or amendment of a performance standard for a device shall—

(i)

set forth a finding with supporting justification that the performance standard is appropriate 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 performance standard is intended to reduce or eliminate,

(iii)

invite interested persons to submit to the Secretary, within 30 days of the publication 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 necessary 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 accordance 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 section 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 performance 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 Register findings on the matters referred to in paragraph (1), or (ii) publish a notice terminating the proceeding for the development of the standard together with the reasons for such termination. If a notice of termination is published, the Secretary shall (unless 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.

(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 Secretary 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 reclassified 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 effective on and after its publication in the Federal Register and until the effective date of any final action taken on such amendment if he determines that making it so effective is in the public interest. A proposed amendment of a performance standard made so effective under the preceding sentence may not prohibit, during the period in which it is so effective, the introduction or delivery for introduction into interstate commerce of a device which conforms to such standard without the change or changes provided by such proposed amendment.

(5)

(A)

The Secretary—

(i)

may on his own initiative refer a proposed 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 referral 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 involved 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 regulation 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 Secretary and other data and information before it, submit to the Secretary a report and recommendation respecting such regulation, together with all underlying data and information and a statement of the reason or basis for the recommendation. A copy of such report and recommendation shall be made public by the Secretary.

(B)

The Secretary shall establish advisory committees (which may not be panels under section 360c of this title) to receive referrals under subparagraph (A). The Secretary shall appoint as members of any such advisory committee persons qualified in the subject matter to be referred to the committee and of appropriately diversified professional background, except that the Secretary may not appoint to such a committee 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 manufacturing 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 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 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 followed by each such committee in acting on referrals made under subparagraph (A).

(1)

(A)

In addition to establishing a performance 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), recognize all or part of an appropriate standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet a premarket submission requirement or other requirement under this chapter to which such standard is applicable.

(B)

If a person elects to use a standard recognized by the Secretary under subparagraph (A) to meet the requirements described in such subparagraph, the person shall provide a declaration of conformity to the Secretary that certifies that the device is in conformity with such standard. A person may elect to use data, or information, other than data required by a standard recognized under subparagraph (A) to meet 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 standard 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 subject 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 appropriate.

(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 accordance with subparagraph (A).

(D)

The Secretary shall make publicly available, in such manner as the Secretary determines 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 regarding such recognition.

(2)

The Secretary may withdraw such recognition of a standard through publication of a notice in the Federal Register if the Secretary determines that the standard is no longer appropriate for meeting a requirement regarding devices under this chapter.

(3)

(A)

Subject to subparagraph (B), the Secretary shall accept a declaration of conformity that a device is in conformity with a standard recognized under paragraph (1) unless the Secretary 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 conformity; or

(ii)

that the standard identified in the declaration 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 respect to a standard recognized under paragraph (1).

(C)

A person making a declaration of conformity 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 employees of the Food and Drug Administration who review premarket submissions for devices periodic training on the concept and use of recognized standards for purposes of meeting a premarket submission requirement or other applicable requirement under this chapter, including standards relevant to an employee’s area of device review.

(d) Accreditation scheme for conformity assessment

(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 meeting criteria specified in guidance by the Secretary, to conduct testing to support the assessment of the conformity of a device to certain standards recognized under this section; and

(B)

subject to paragraph (2), results from tests conducted to support the assessment of conformity of devices as described in subparagraph (A) conducted by testing laboratories accredited pursuant to this subsection shall be accepted by the Secretary for purposes of demonstrating such conformity unless 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 processes of accredited bodies or testing laboratories;

(B)

following such review, take additional measures under this chapter, as the Secretary determines appropriate, such as—

(i)

suspension or withdrawal of accreditation of a testing laboratory or recognition of an accreditation body under paragraph (1)(A); or

(ii)

requesting additional information with respect to a device; and

(C)

if the Secretary becomes aware of information materially bearing on the safety or effectiveness of a device for which an assessment 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 accreditation of a testing laboratory or recognition of an accreditation body under paragraph (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 Administration an annual report on the progress of the program under this subsection.

Source credit: (June 25, 1938, ch. 675, § 514, as added Pub. L. 94–295, § 2, May 28, 1976, 90 Stat. 546; amended 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.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 94-295 · 90 Stat. 546
1976Amended · Pub. L. 94-460 · 90 Stat. 1960
1990Amended · Pub. L. 101-629 · 104 Stat. 4519, 4528
1992Amended · Pub. L. 102-300 · 106 Stat. 241
1993Amended · Pub. L. 103-80 · 107 Stat. 779
1997Amended · Pub. L. 105-115 · 111 Stat. 2335, 2336
2012Amended · Pub. L. 112-144 · 126 Stat. 1056
2016Amended · Pub. L. 114-255 · 130 Stat. 1121, 1125
2017Amended · Pub. L. 115-52 · 131 Stat. 1016
2022Amended · Pub. L. 117-180 · 136 Stat. 2153

A history note hasn’t been published yet. The record shows enactment by Pub. L. 94-295 on 1938-06-25.

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