21 U.S.C. § 360d : US Code - Section 360D: Performance standards

Search 21 U.S.C. § 360d : US Code - Section 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 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) of this section if the
device has been reclassified as a class II device under a
regulation under section 360c(e) of this title but such 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) of
this section 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) of this
section 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) of this section, 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).
(c) Recognition of standard
(1)(A) In addition to establishing a performance standard under
this section, the Secretary shall, by publication in the Federal
Register, 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.
(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.