tition, such as under §860.130, §860.132, or $860.136, the Commissioner will distribute a copy of the petition, or its relevant portions, to each panel member and will consult with the panel in one of the following ways:

(1) Consultation by telephone with at least a majority of current voting panel members and, when possible, nonvoting panel members;

(2) Consultation by mail with at least a majority of current voting panel members and, when possible, nonvoting panel members; and

(3) Discussion at a panel meeting.

(b) The method of consultation chosen by the Commissioner will depend upon the importance and complexity of the subject matter involved and the time available for action. When time and circumstances permit, the Commissioner will consult with a panel through discussion at a panel meeting. (c) When a petition is submitted under $860.134 for a post-enactment, not substantially equivalent device ("new device"), in consulting with the panel the Commissioner will obtain a recommendation that includes the information described in §860.84(d). In consulting with a panel about a petition submitted under §860.130, §860.132, or $860.136, the Commissioner may or may not obtain a formal recommendation.

(a) Section 513(e) of the act applies to reclassification proceedings under the act based upon new information.

(b) A proceeding to reclassify a device under section 513(e) may be initiated:

(1) On the initiative of the Commissioner alone;

(2) On the initiative of the Commissioner in response to a request for change in classification based upon new information, under section 514(b) or 515(b) of the act (see §860.132); or

(3) In response to the petition of an interested person, based upon new information, filed in accordance with §860.123.

(c) By regulation promulgated under this section, the Commissioner may

change the classification from class III into:

(1) Class II if the Commissioner determines that special controls in addition to general controls would provide reasonable assurance of the safety and effectiveness of the device and there is sufficient information to establish special controls to provide assurance; or

(2) Class I if the Commissioner determines that general controls would provide reasonable assurance of the safety and effectiveness of the device.

(d) The rulemaking procedures in §10.40 of this chapter apply to proceedings to reclassify a device under section 513(e), except that the Commissioner may secure a recommendation with respect to a proposed reclassification from the classification panel to which the device was last referred. The panel will consider a proposed reclassification submitted to it by the Commissioner in accordance with the consultation procedures of §860.125. Any recommendation submitted to the Commissioner by the panel will be published in the FEDERAL REGISTER when the Commissioner promulgates a regulation under this section.

(e) Within 180 days after the filing of a petition for reclassification under this section, the Commissioner, by order published in the FEDERAL REGISTER, will either deny the petition or give notice of his intent to initiate a change in the classification of the device.

(f) If a device is reclassified under this section, the regulation effecting the reclassification may revoke any special control or premarket approval requirement that previously applied to the device but that is no longer applicable because of the change in classification.

(g) A regulation under this section changing the classification of a device from class III to class II may provide that such classification will not take effect until the effective date of a special control for the device established under section 514 of the act.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992]

§860.132 Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the act.

(a) Sections 514(b) and 515(b) of the act require the Commissioner to provide, by notice in the FEDERAL REGISTER, an opportunity for interested parties to request a change in the classification of a device based upon new information relevant to its classification when the Commissioner initiates a proceeding either to develop a performance standard for the device if in class II, or to promulgate a regulation requiring premarket approval for the device if in class III. In either case, if the Commissioner agrees that the new information warrants a change in classification, the Commissioner will publish in the FEDERAL REGISTER notice of the Commissioner's intent to initiate a proceeding under section 513(e) of the act and §860.130 to effect such a change.

(b) The procedures for effecting a change in classification under sections 514(b) and 515(b) of the act are as follows:

(1) Within 15 days after publication of the Commissioner's notice referred to in paragraph (a) of this section, an interested person files a petition for reclassification in accordance with § 860.123.

(2) The Commissioner consults with the appropriate classification panel with regard to the petition in accordance with § 860.125.

(3) Within 60 days after publication of the notice referred to in paragraph (a) of this section, the Commissioner, by order published in the FEDERAL REGISTER, either denies the petition or gives notice of his intent to initiate a change in classification in accordance with § 860.130.

§ 860.134 Procedures for "new devices" under section 513(f) of the act and reclassification of certain devices.

(a) Section 513(f)(2) of the act applies to proceedings for reclassification of a device currently in class III by operation of section 513(f)(1) of the act. This category includes any device that is to be first introduced or delivered for introduction into interstate commerce

for commercial distribution after May 28, 1976, unless:

(1) It is substantially equivalent to another device that was in commercial distribution before that date and had not been regulated before that date as a new drug; or

(2) It is substantially equivalent to another device that was not in commercial distribution before such date but which has been classified into class I or class II; or

(3) The Commissioner has classified the device into class I or class II in response to a petition for reclassification under this section.

The Commissioner determines whether a device is "substantially equivalent" for purposes of the application of this section. If a manufacturer or importer believes that a device is not "substantially equivalent" but that it should not be in class III under the criteria in §860.3(c), the manufacturer or importer may petition for reclassification under this section. A manufacturer or importer who believes that a device is "substantially equivalent" and wishes to proceed to market the device shall submit a premarket notification in accordance with Part 807 of this chapter. After considering a premarket notification, the Commissioner will determine whether the device is "substantially equivalent" and will notify the manufacturer or importer of such determination in accordance with Part 807 of this chapter.

(b) The procedures for effecting reclassification under section 513(f) of the act are as follows:

(1) The manufacturer or importer of the device petitions for reclassification of the device in § 860.123.

accordance with

(2) Within 30 days after the petition is filed, the Commissioner notifies the petitioner of any deficiencies in the petition that prevent the Commissioner from making a decision on it and allows the petitioner to supplement a deficient petition. Within 30 days after any supplemental material is received, the Commissioner notifies the petitioner whether the petition, as supplemented, is adequate for review.

(3) After determining that the petition contains no deficiencies precluding a decision on it, the Commissioner

may for good cause shown refer the petition to the appropriate classification panel for its review and recommendation whether to approve or deny the petition.

(4) Within 90 days after the date the petition is referred to the panel, following the review procedures set forth in §860.84(c) for the original classification of an "old" device, the panel submits to the Commissioner its recommendation containing the information set forth in §860.84(d). A panel recommendation is regarded as preliminary until the Commissioner has reviewed it, discussed it with the panel, if appropriate, and developed a proposed reclassification order. Preliminary panel recommendations are filed in the Dockets Management Branch upon receipt and are available to the public upon request.

(5) The panel recommendation is published in the FEDERAL REGISTER as soon as practicable and interested persons are provided an opportunity to comment on the recommendation.

(6) Within 90 days after the panel's recommendation is received (and no more than 210 days after the date the petition was filed), the Commissioner denies or approves the petition by order in the form of a letter to the petitioner. If the Commissioner approves the petition, the order will classify the device into class I or class II in accordance with the criteria set forth in §860.3(c) and subject to the applicable requirements of §860.93, relating to the classification of implants, life-supporting or life-sustaining devices, and §860.95, relating to exemptions from certain requirements of the act.

(7) Within a reasonable time after issuance of an order under this section, the Commissioner announces the order by notice published in the FEDERAL REGISTER.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992]

$860.136 Procedures for transitional products under section 520(1) of the act.

(a) Section 520(1)(2) of the act applies to reclassification proceedings initiated by a manufacturer or importer for reclassification of a device currently in class III by operation of section

520(1)(1) of the act. This section applies only to devices that the Food and Drug Administration regarded as "new drugs" before May 28, 1976.

(b) The procedures for effecting reclassification under section 520(1) are as follows:

(1) The manufacturer or importer of the device files a petition for reclassification of the device in accordance with §860.123.

(2) Within 30 days after the petition is filed, the Commissioner notifies the petitioner of any deficiencies in the petition that prevent the Commissioner from making a decision on it, allowing the petitioner to supplement a deficient petition. Within 30 days after any supplemental material is received, the Commissioner notifies the petitioner whether the petition, as supplemented, is adequate for review.

(3) The Commissioner provides the petitioner an opportunity for a regulatory hearing conducted in accordance with Part 16 of this chapter.

(4) The Commissioner consults with the appropriate classification panel with regard to the petition in accordance with § 860.125.

(5) Within 180 days after the petition is filed (where the Commissioner has determined it to be adequate for review), the Commissioner, by order in the form of a letter to the petitioner, either denies the petition or classifies the device into class I or class II in accordance with the criteria set forth in § 860.3(c).

(6) Within a reasonable time after issuance of an order under this section, the Commissioner announces the order by notice published in the FEDERAL REGISTER.

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: Secs. 501, 502, 513, 514, 530-542, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360c, 360d, 360gg360ss, 371, 374); secs. 351, 361 of the Public Health Service Act (42 U.S.C. 262, 264).

SOURCE: 45 FR 7484, 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 II 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 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]

§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 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 Administra

tion, within 30 days of the publication of the notice, requests for changes in the classification of the device pursuant to §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 §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. [57 FR 58404, Dec. 10, 1992]

§ 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: