(a) Before initiating a proceeding to make a device a banned device, the Commissioner shall find that the continued marketing of the device presents a substantial deception or an unreasonable and substantial risk of illness or injury.

(1) In determining whether the deception or risk of illness or injury is substantial, the Commissioner will consider whether the deception or risk posed by continued marketing of the device, or continued marketing of the device as presently labeled, is important, material, or significant in relation to the benefit to the public health from its continued marketing.

(2) In determining whether a device is deceptive, the Commissioner will consider whether users of the device may be deceived or otherwise harmed by the device. The Commissioner is not required to determine that there was an intent on the part of the manufacturer, distributor, importer, or any other responsible person(s) to mislead or otherwise harm users of the device or that there exists any actual proof of deception of, or injury to, an individual.

(3) In determining whether a device presents deception or risk of illness or injury, the Commissioner will consider all available data and information, including data and information that the Commissioner may obtain under other provisions of the act, data and information that may be supplied by the manufacturer, distributor, or importer of the device under §895.22, and data and information voluntarily submitted by any other interested persons.

(b) Before initiating a proceeding to make a device a banned device, the Commissioner of Food and Drugs (the Commissioner) may consult with the panel established under section 513 of the act that has expertise with respect to the type of device under consideration. The consultation with the panel may occur at a regular or specially scheduled panel meeting or may be accomplished by correspondence or telephone conversation with panel members. The Commissioner may request that the panel submit in writing any advice on the device under consideration. The Commissioner will record in written memoranda any oral communications with a panel or its members.

(c) If the Commissioner determines that any substantial deception or unreasonable and substantial risk of illness or injury or any unreasonable, direct, and substantial danger to the health of individuals presented by a device can be corrected or eliminated by labeling or change in labeling, or change in advertising if the device is a restricted device, the Commissioner will notify the responsible person of the required labeling or change in labeling or change in advertising in accordance with §895.25. If such required relabeling or change in advertising is not accomplished in accordance with §895.25, the Commissioner may initiate a proceeding to ban the device in accordance with §895.21(d) and, when appropriate, may establish a special effective date in accordance with §895.30.

(d) If the Commissioner decides to initiate a proceeding to make a device a banned device, a notice of proposed rulemaking will be published in the Federal Register to this effect. The notice will briefly summarize—

(1) The Commissioner's finding under paragraph (a) of this section that the device presents substantial deception or an unreasonable and substantial risk of illness or injury, and, when appropriate, the Commissioner's determination under §895.30 that the deception or risk of illness or injury presents an unreasonable, direct, and substantial danger to the health of individuals;

(2) The reasons why the Commissioner initiated the proceeding;

(3) The evaluation of data and information obtained under other provisions of the act, submitted by the manufacturer, distributer, or importer of the device, or voluntarily submitted by any other interested persons under paragraph (a)(3) of this section, if any;

(4) The consultation with the panel, if any, under paragraph (b) of this section;

(5) The determination as to whether the deception or risk of illness or injury or the danger to the health of individuals could be corrected by labeling or change in labeling, or change in advertising if the device is a restricted device;

(6) The determination of whether the required labeling or change of labeling, or change in advertising if the device is a restricted device, if any, has been made in accordance with paragraph (c) of this section;

(7) The determination as to whether, and the reasons why, the banning should apply to devices already in commercial distribution or those already sold to the ultimate user, or both; and

(8) Any other data and information that the Commissioner believes are pertinent to the proceeding. The notice will afford all interested persons an opportunity to submit written comments within 30 days after the date of publication of the proposed regulation. All nonconfidential information upon which the proposed finding is based, including the recommendations of the panel, will be available for public review in the Division of Dockets Management, Food and Drug Administration.

(e)

(1) If, after reviewing the administrative record of the regulatory hearing before the Food and Drug Administration, if any, the written comments received on the proposed regulation, and any additional available data and information, the Commissioner determines to ban a device, a final regulation to this effect will be published in the Federal Register. The final regulation will amend subpart B by adding the name or description of the device, or both, to the list of banned devices.

(2) If the Commissioner determines not to ban the device, a notice of withdrawal and termination of rulemaking proceedings and reasons therefor will be published in the Federal Register.

(f) The effective date of a final regulation to make a device a banned device, promulgated under paragraph (e) of this section, will be the date of publication of the final regulation in the Federal Register unless the Commissioner, for reasons stated, determines that the effective date should be later than the date of the publication and specifies that date in the notice. Each such regulation will specify whether devices already in commercial distribution or sold to the ultimate user or both are banned.

(g) A regulation promulgated under paragraph (e) of this section is final agency action, subject to judicial review under section 517 of the act.

(h) Upon petition of any interested person submitted in accordance with §10.30 of this chapter, or as a matter of discretion, the Commissioner may institute proceedings to amend or revoke a regulation that made a device a banned device if the Commissioner finds that the conditions that constituted the basis for the regulation banning the device are no longer applicable. When appropriate, the procedures in this section will be employed in such proceedings.

[44 FR 29221, May 18, 1979, as amended at 53 FR 11254, Apr. 6, 1988; 57 FR 58405, Dec. 10, 1992; 65 FR 43690, July 14, 2000]