[Title 21 CFR 861]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 861 - PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT]
[From the U.S. Government Printing Office]
21FOOD AND DRUGS81999-04-011999-04-01falsePROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT861PART 861FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICES
PART 861--PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT--Table of Contents
Subpart A--General
Sec.
861.1 Purpose and scope.
861.5 Statement of policy.
861.7 Contents of standards.
Subpart B--Procedures for Performance Standards Development and
Publication
861.20 Summary of standards development process.
861.24 Existing standard as a proposed standard.
861.30 Development of standards.
861.34 Amendment or revocation of a standard.
861.36 Effective dates.
861.38 Standards advisory committees.
Authority: 21 U.S.C. 351, 352, 360c, 360d, 360gg-360ss, 371, 374; 42
U.S.C. 262, 264.
Source: 45 FR 7484, Feb. 1, 1980, unless otherwise noted.
Subpart A--General
Sec. 861.1 Purpose and scope.
(a) This part implements section 514 of the Federal Food, Drug, and
Cosmetic Act (the act) with respect to the
[[Page 176]]
establishment, amendment, and revocation of performance standards
applicable to devices intended for human use.
(b) The Food and Drug Administration may determine that a
performance standard, as described under special controls for class II
devices in Sec. 860.7(b) of this chapter, is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Performance standards may be established for:
(1) A class II device;
(2) A class III device which, upon the effective date of the
standard, is reclassified into class II; and
(3) A class III device, as a condition to premarket approval under
section 515 of the act, to reduce or eliminate a risk or risks
associated with such device.
(c) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21 unless otherwise noted.
[45 FR 7484, Feb. 1, 1980, as amended at 45 FR 23686, Apr. 8, 1980; 57
FR 58404, Dec. 10, 1992]
Sec. 861.5 Statement of policy.
In carrying out its duties under this section, the Food and Drug
Administration will, to the maximum extent practical:
(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 participation, through conferences, workshops, or other
means, by representatives of scientific, professional, industry, or
consumer organizations who can make a significant contribution.
Sec. 861.7 Contents of standards.
Any performance standard established under this part will include
such provisions as the Food and Drug Administration determines are
necessary to provide reasonable assurance of the safety and
effectiveness of the device or devices for which it is established.
Where necessary to provide such assurance, a standard will address (but
need not be limited to):
(a) Performance characteristics of the device;
(b) The design, construction, components, ingredients, and
properties of the device, and its compatibility with power systems and
connections to such systems;
(c) The manufacturing processes and quality control procedures
applicable to the device;
(d) Testing of the device on either a sample or a 100-percent basis
by the manufacturer, or, if it is determined that no other more
practical means are available to the Food and Drug Administration to
assure the conformity of the device to the standard, providing for
testing by the Food and Drug Administration or a third person to ensure
that the device conforms to the standard;
(e) The publication of the results of each test or of certain tests
of the device to show that the device conforms to the portions of the
standard for which the test or tests were required;
(f) Manufacturers' certification to purchasers or to the Food and
Drug Administration that the device conforms to the applicable
performance standard;
(g) Restrictions on the sale and distribution of the device, but
only to the extent authorized under section 520(e) of the act;
(h) The use, and the form and content, of labeling for the proper
installation, maintenance, operation, and use of the device. Among the
provisions that may be required in the labeling are warnings; storage
and transportation information; expiration dates; the date and place of
manufacture; the results that may be expected if the device is used
properly; the ranges of accuracy of diagnostic information; instructions
regarding the proper care of, and the proper components, accessories, or
other equipment to be used with the device; and statements concerning
the appropriate patient population, for example, a statement that the
device is considered safe and effective only when used by, or in the
treatment of, a patient who has been tested by particular designated
procedures
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and found to have an illness or condition for which use of the device is
indicated by a person skilled in the use of the device.
Subpart B--Procedures for Performance Standards Development and
Publication
Sec. 861.20 Summary of standards development process.
The procedure by which a performance standard for a device may be
established, amended, or revoked is as follows:
(a) The Food and Drug Administration (FDA) will publish in the
Federal Register a notice of proposed rulemaking for the establishment,
amendment, or revocation of any performance standard for a device.
(1) A notice of proposed rulemaking for the establishment or
amendment of a performance standard for a device will:
(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 Food and Drug
Administration, within 30 days of the publication of the notice,
requests for changes in the classification of the device pursuant to
Sec. 860.132 of this chapter, 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 Commissioner of Food and Drugs.
(2) A notice of proposed rulemaking for the revocation of a
performance standard will 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.
(b) A notice under this section will provide for a comment period of
not less than 60 days.
(c) If, after publication of a notice under paragraph (a) of this
section, FDA receives a request to change the classification of the
device, FDA will, within 60 days of the publication of the notice and
after consultation with the appropriate panel under Sec. 860.125 of this
chapter, either deny the request or give notice of its intent to
initiate a change in the classification under Sec. 860.130.
(d) If FDA initiates a rulemaking proceeding under paragraph (a) of
this section, FDA will:
(1) Complete the proceeding and establish the performance standard
for the device in accordance with this part and Sec. 10.40 of this
chapter; or
(2) Terminate the proceeding by publishing in the Federal Register a
notice announcing such termination and the reasons therefor and, unless
the proceeding is terminated because the device is a banned device,
initiate a proceeding in accordance with section 513(e) of the act to
reclassify the device; or
(3) Take other appropriate action.
[57 FR 58404, Dec. 10, 1992]
Sec. 861.24 Existing standard as a proposed standard.
(a) The Food and Drug Administration may accept an existing standard
or a proposed or draft standard if it includes:
(1) A description of the procedures used to develop the standard and
a list of the persons and organizations that participated in its
development, to the extent that such information is available or
reasonably obtainable;
(2) An identification of the specific portions of the existing
standard that the person submitting the standard believes are
appropriate for adoption as, or inclusion in, the proposed standard; and
(3) A summary of the test data, or, if requested by the Food and
Drug Administration, all such data or other information supporting the
specific portions of the standard identified by the person submitting
the standard.
(b) The Food and Drug Administration will publish a notice in the
Federal Register stating either that it
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has accepted, or accepted with modification, as a proposed standard, an
existing standard or one that has been developed, or that an existing
standard is not acceptable, together with the reasons therefor.
[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]
Sec. 861.30 Development of standards.
The Food and Drug Administration (FDA), while engaged in the
development of a proposed standard under this section will:
(a) Support its proposed performance standard by such test data or
other documents or materials as may reasonably be required;
(b) Provide interested persons an opportunity to participate in the
development of the standard by accepting comments and, where
appropriate, holding public meetings on issues relating to development
of the standard. Notice of the opportunity to participate in the
development of the standard will be furnished in a manner reasonably
calculated to reach the majority of persons interested in the
development of the standard. This requirement shall be satisfied by
publishing such a notice in the Federal Register. Whenever it is
appropriate, FDA will use the Federal Register to make announcements
about the standard development process of standard developers other than
Federal agencies.
(c) Maintain records disclosing the course of development of the
proposed standard, the comments and other information submitted by a
person in connection with such development (including comments and
information regarding the need for a standard), and such other
information as may be required to evaluate the standard.
[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]
Sec. 861.34 Amendment or revocation of a standard.
(a) The Food and Drug Administration will provide for periodic
evaluation of performance standards to determine whether such standards
should be changed to reflect new medical, scientific, or other
technological data.
(b) The Food and Drug Administration may, on its own initiative or
upon petition of an interested party, amend or revoke by regulation a
standard established under this part.
(c) Any petition to amend or revoke a standard shall:
(1) Identify the specific device and standard for which the
amendment or revocation is sought; and
(2) Be submitted in accordance with the requirements of Sec. 10.30.
(d) Proceedings to amend or revoke a performance standard shall be
conducted in accordance with the rulemaking procedures of Sec. 10.40. In
addition, a notice of proposed rulemaking to amend or revoke a standard
shall set forth proposed findings with respect to the degree of risk or
illness to be eliminated or reduced and the benefit the public will
derive from the proposed amendment or revocation.
Sec. 861.36 Effective dates.
(a) A regulation establishing, amending, or revoking a performance
standard will set forth the date upon which it will take effect. To the
extent practical, consistent with the public health and safety, such
effective date will be established so as to minimize economic loss to,
and disruption or dislocation of, domestic and international trade.
(b) Except as provided in paragraph (c) of this section, no
regulation establishing, amending, or revoking a standard may take
effect before 1 year after the date of its publication unless:
(1) The Food and Drug Administration determines that an earlier
effective date is necessary to protect the public health and safety; or
(2) The standard has been established for a device that, by the
effective date of the standard, has been reclassified from class III to
class II.
(c) The Food and Drug Administration may declare a proposed
regulation amending a standard effective on publication in the Federal
Register if it determines that making the regulation so effective is in
the public interest. A proposed amendment of a performance standard made
effective upon publication may not prohibit the introduction or delivery
for introduction into interstate commerce of a device that conforms to
the standard without the
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change or changes provided in the proposed amendment until the effective
date of any final action on the proposal.
[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]
Sec. 861.38 Standards advisory committees.
(a) The Food and Drug Administration will establish advisory
committees to which proposed regulations may be referred, and these
committees shall consider such referrals in accordance with this section
and part 14 of this chapter. Such advisory committees, which may not be
classification panels, shall be considered ad hoc advisory committees.
Their members shall be selected in accordance with Secs. 14.82 and
14.84, except that no member may be a regular full-time FDA employee.
Each advisory committee established under this section shall include as
nonvoting members a representative of consumer interests and a
representative of interests of the device manufacturing industry.
(b) A proposed regulation to establish, amend, or revoke a
performance standard shall be referred to an advisory committee for a
report and recommendation with respect to any matter involved in the
proposed regulation which requires the exercise of scientific judgment
if:
(1) The Food and Drug Administration determines that such referral
is necessary or appropriate under the circumstances; or
(2) Requested by an interested person, in the form of a citizen
petition in accordance with Sec. 10.30 of this chapter, which is made
within the period provided for comment on the proposed regulation and
which demonstrates good cause for referral.
(c) When a proposed regulation is referred to an advisory committee,
the Food and Drug Administration will furnish the committee with the
data and information upon which the proposed regulation is based. After
independently reviewing the materials furnished by the Food and Drug
Administration and any other available data and information, the
advisory committee shall, within 60 days of the referral, submit a
report and recommendation on the proposed regulation, together with all
underlying data and information and a statement of the reason or basis
for the recommendation. A copy of the report and recommendation will be
publicly displayed in the office of the Dockets Management Branch, Food
and Drug Administration.
(d) Where appropriate, each proposed regulation establishing a
standard published in the Federal Register will include a call for
nominations to the advisory committee for that particular standard.
[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]