21 CFR Part 860 (up to date as of 10-15-2024)&21 CFR Part 861 (up to date as of 10-15-2024) 2024.10.15

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21CFR Part 861(up to date as of10/15/2024)

Procedures for Performance Standards Development

This content is from the eCFR and is authoritative but unofficial.

Title 21-Food and Drugs

ChapterI—Food and Drug Administration,Department of Health and Human Services

Subchapter H一Medical Devices

Part 861 Procedures for Performance Standards Development

SubpartA General

§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.

PART 861—PROCEDURES FOR PERFORMANCE STANDARDS

DEVELOPMENT

Authority: 21 U.S.C.351,352,360c,360d,360gg-360ss,371,374;42 U.S.C.262,264.

Source: 45 FR7484.Feb.1.1980.unless otherwise noted.

Subpart A-General

§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 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 Il devices in§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 Il device;

(2)A class I device which,upon the effective date of the standard,is reclassified into class II;and

(3)A clasⅢI 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.

21CFR861.1(b)(3)(enhanced display) page 1of 6

21CFR Part 861(Oct.15,2024)

21CFR Part 861(up to date as of10/15/2024)

Procedures for Performance Standards Development

21CFR 861.1(c)

(c)References in this part to regulatory sections of the Code of Federal Regulations are to chapter l 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]

§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.

§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

21CFR 861.7(h)(enhanced display) page 2 of 6

21CFR Part 861(up to date as of10/15/2024)

Procedures for Performance Standards Development

21CFR861.20(d)(3)(enhanced display) page 3 of 6

21CFR861.20

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 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

§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 toS

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.

classification of the device,FDA will,within 60 days of the publication of the notice and after consultation

with the appropriate panel under §860.125 of this chapter,either deny the request or give notice of its

intent to initiate a change in the classification under §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 §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.

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21 CFR Part 860 (up to date as of 10-15-2024)&21 CFR Part 861 (up to date as of 10-15-2024) 2024.10.15

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