lowing the review procedures set forth in § 860.84(c) for the original classifiIcation 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.

§ 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 reclassifi

cation 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 A-General

§ 861.1 Purpose and scope.

(a) This part implements section 514 of the act with respect to the initiation, development, establishment, amendment, and revocation of performance standards applicable to devices intended for human use.

(b) 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]

§ 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, profes

sional, 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 developed and promulgated is as follows: (a) The Food and Drug Administration will initiate a proceeding for the development of a performance standard for a device by publishing in the FEDERAL REGISTER a notice of opportunity to request (within 15 days of the date of publication of the notice) reclassification of the device in accordance with § 860.130.

(b) If, after publication of a notice under paragraph (a) of this section, the Food and Drug Administration receives a request to change the classification of the device, the Food and Drug Administration will, within 60 days of the publication of the notice, by order published in the FEDERAL REGISTER, either deny the request or give notice of intent to initiate a change in the classification.

(c) If the Food and Drug Administration determines that the device will remain classified in class II, a notice will be published in the FEDERAL REGISTER inviting any person, including any Federal agency, to submit within 60 days after the date of publication, either an existing standard as a proposed performance standard or an offer to develop such a standard.

(d) Following expiration of the 60day period, the Food and Drug Administration will:

(1) Authorize a Federal agency to develop a proposed performance standard if the Food and Drug Administration determines that a performance standard can be developed by a Federal agency, based on the personnel, expertise, and resources of the agency;

or

(2) Accept an existing standard as a proposed performance standard or as a basis upon which a proposed performance standard may be developed. An existing standard may be one that is submitted in response to the invitation for standards or it may be a standard that has been issued or adopted (or is being developed) by any Federal agency or any other qualified entity. The Food and Drug Administration will determine that such a standard is based upon scientific data and information and has been subjected to adequate scientific consideration; or

(3) Accept one or more offers to develop a proposed standard; or

(4) Proceed to develop a proposed standard; or

(5) Take other appropriate action to facilitate development of a performance standard for the device.

(e) After publication of a notice inviting the submission of an existing standard as a proposed performance standard or an offer to develop such a standard in accordance with § 861.22, the Food and Drug Administration may either:

(1) Publish in the FEDERAL REGISTER, in a notice of proposed rulemaking in accordance with § 10.40, a proposed performance standard for the device (the notice of proposed rulemaking will include proposed findings with respect to the degree of risk of illness or injury the proposed standard is designed to eliminate or reduce and the benefit to the public from the device);

or

(2) Terminate the proceeding to develop and promulgate a performance standard by publishing in the FEDERAL REGISTER a notice to that effect, together with the reasons therefor and, unless such notice is issued because the device is a banned device under section 516 of the act, initiate a pro

ceeding under section 513(e) of the act to reclassify the device; or

(3) Take other appropriate action.

(f) If the Food and Drug Administration initiates a rulemaking proceeding under paragraph (e)(1) of this section, the Food and Drug Administration will:

(1) Complete the proceeding and establish the performance standard for the device in accordance with this part and § 10.40; 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.

§ 861.22 Invitation for a standard.

The notice to be published in the FEDERAL REGISTER inviting offers to develop a performance standard will contain the following information:

(a) The time period within which the standard is to be developed, which may be extended by the Food and Drug Administration for good cause;

(b) A description or other designation of the device for which a performance standard may be established;

(c) A statement of the risks associated with use of the device and which are intended to be controlled by a performance standard, including pertinent portions of panel classification recommendations with respect to the

device;

(d) A summary of the data from which the Food and Drug Administration has determined a need for initiation of the proceeding to develop a performance standard, including pertinent portions of the recommendations of classification panels with respect to the device;

(e) Identification of any existing performance standard known to the Food and Drug Administration that may be relevant to the proceeding; and

(f) The approximate number of products (i.e., kinds of models) within the generic type of device that may be subject to the performance standard.

§ 861.24 Existing standard as a proposed standard.

(a) The Food and Drug Administration may accept an existing standard or a standard that is being developed, 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 has accepted, or has accepted with modification, as a proposed standard, an existing standard or one that is being developed, or that an existing standard is not acceptable, together with the reasons therefor.

§ 861.26 Offer to develop a proposed standard.

(a) The Food and Drug Administration may consider any offers to develop a proposed standard that include:

(1) Information on the offeror's expertise and experience that qualifies the offeror to develop a proposed standard for the particular device;

(2) Sufficient information on the offeror's financial stability to establish capability to conduct adequate standards development either with or without contribution by the Food and Drug Administration to the offeror's costs;

(3) Information relating to any potential conflicts of interest on the part of the offeror, its directors or officers, or any employees or consultants who may participate in the development of the standard, including any financial interest in the particular device or in the device industry generally, current

(5) A detailed description of the procedures the offeror intends to utilize in developing the standard;

(6) A description of how the offeror intends to provide interested persons adequate and reasonable notice of their right and opportunity to participate in the development of the standard;

(7) A description of the method whereby interested persons who respond to the notice may participate, either in person or through correspondence, in the development of the standard;

(8) A statement describing the facilities or equipment the offeror intends to utilize in developing the standard, and how the offeror intends to gain access to them;

(9) An estimate of the time required to develop the standard, including a detailed schedule for each phase of the procedure;

(10) A description of the method the offeror intends to use or has used to acquire test data or other information needed to support the standard;

(11) A description of the method the offeror intends to use to maintain records of the development of the standard and other relevant matters and to make such records available for disclosure during development, and a schedule for meeting the periodic reporting requirements of § 861.30(b);

(12) If the offeror desires, a request for contribution by the Food and Drug Administration to the offeror's cost of developing the standard, which shall include:

(i) A list of the items of expense for which contribution is sought and the amount requested for each item;

(ii) A justification of each item of expense, including an explanation of how the contribution is likely to ensure development of a more satisfactory standard;

(iii) A statement that the offeror will employ an adequate accounting system (one in accordance with generally accepted accounting principles) to record the costs and expenditures allocable to development of the standard; and

(iv) A statement requesting an advance payment of funds, if necessary to enable the offeror to meet operating expenses during the development period.

(b) Information included in an offer to develop a proposed standard is to be made available to the public only if the offer is accepted (except for information exempt from disclosure under § 20.61), or if disclosure is required under Part 20 of this chapter.

[45 FR 7484, Feb. 1, 1980, as amended at 50 FR 16669, Apr. 26, 1985]

§ 861.28 Acceptance of offer to develop a standard.

(a) In determining whether to accept an offer to develop a performance standard, the Food and Drug Administration will evaluate the qualifications of the offeror on the basis of the offeror's expertise, experience, financial stability, and potential conflicts of interest. In choosing among competing offerors, the offerors with no financial interest in the particular device for which a proposed standard is sought or in the device industry generally will be preferred, all other things being equal.

(b) If the conditions provided in § 861.20(d)(3) have been met, and one or more offers that satisfy the requirements of § 861.26 have been submitted, one or more qualifying offers to develop a proposed standard may be accepted.

(c) The Food and Drug Administration will publish in the FEDERAL REGISTER the name and address of each person whose offer to develop a standard is accepted and a summary of the terms of the accepted offer, including a statement of the extent to which the Food and Drug Administration will contribute, if at all, to the cost of developing the proposed standard.

(d) If the Food and Drug Administration does not accept an offer to develop a proposed standard submitted