(a) This part describes the procedures by which the Commissioner may institute proceedings to make a device intended for human use that presents substantial deception or an unreasonable and substantial risk of illness or injury a banned device.

(b) This part applies to any “device”, as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (act) that is intended for human use.

(c) A device that is made a banned device in accordance with this part is adulterated under section 501(g) of the act. A restricted device that is banned may also be misbranded under section 502(q) of the act.

(d) Although this part does not cover devices intended for animal use, the manufacturer, distributor, importer, or any other person(s) responsible for the labeling of the device that is banned cannot avoid the ban by relabeling the device for veterinary use. A device that has been banned from human use but that also has a valid veterinary use may be marketed for use as a veterinary device only under the following conditions: The device shall comply with all requirements applicable to veterinary devices under the Federal Food, Drug, and Cosmetic Act and this chapter, and the label for the device shall bear the following statement: “For Veterinary Use Only. Caution: Federal law prohibits the distribution of this device for human use.” A device so labeled, however, that is determined by the Food and Drug Administration to be intended for human use, will be considered to be a banned device. In determining whether such a device is intended for human use, the Food and Drug Administration will consider, among other things, the ultimate destination of the device.

The Commissioner may initiate a proceeding to make a device a banned device whenever the Commissioner finds, on the basis of all available data and information, that the device presents substantial deception or an unreasonable and substantial risk of illness or injury that the Commissioner determines cannot be, or has not been, corrected or eliminated by labeling or by a change in labeling, or by a change in advertising if the device is a restricted device.

(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.

(a) A manufacturer, distributor, or importer of a device may be required to submit to the Food and Drug Administration all relevant and available data and information to enable the Commissioner to determine whether the device presents substantial deception, unreasonable and substantial risk of illness or injury, or unreasonable, direct, and substantial danger to the health of individuals. The data and information required by the Commissioner may include scientific or test data, reports, records, or other information, including data and information on whether the device is safe and effective for its intended use or when used as directed, whether the device performs according to the claims made for the device, and information on adulteration or misbranding. Any relevant information that is voluntarily submitted will also be reviewed.

(b) A manufacturer, distributor, or importer of a device required to submit data and information as provided in paragraph (a) of this section will be notified in writing by the Food and Drug Administration that such data and information shall be submitted. The written notification will advise the manufacturer, distributor, or importer of the device that the purpose for the request is to enable the Commissioner to determine whether any of the conditions listed in paragraph (a) of this section or § 895.30(a)(1) exists with respect to the device such that a proceeding should be initiated to make the device a banned device. When the required data and information can be identified by the Food and Drug Administration at the time of the notification, the agency will provide such identification to the manufacturer, distributor, or importer of the device.

(c) The required data and information shall be submitted to the Food and Drug Administration no more than 30 days after the date of receipt of the request, unless the Commissioner determines that the data and information shall be submitted by some other date and so informs the manufacturer, distributor, or importer, in which case the data and information shall be submitted on the date specified by the Commissioner.

(d) If the data or information submitted to the Food and Drug Administration is sufficient to persuade the Commissioner that the deception or risk of illness or injury or the danger to the health of individuals presented by a device could be corrected or eliminated by labeling or change in labeling, or change in advertising if the device is a restricted device, the Commissioner will proceed in accordance with § 895.25.

(e) If the data or information submitted to the Food and Drug Administration is insufficient to show that the device does not present a substantial deception or an unreasonable and substantial risk of illness or injury, or an unreasonable, direct, and substantial danger to the health of individuals, or if the manufacturer, distributor, or importer fails to submit the required information, the Commissioner may rely upon this insufficiency or failure to submit the required information in considering whether to initiate a proceeding to make the device a banned device under § 895.21(d) and, when appropriate, to establish a special effective date in accordance with § 895.30. The Commissioner may also initiate other regulatory action as provided in the act or this chapter.

(a) If the Commissioner determines that the substantial deception or unreasonable and substantial risk of illness or injury or the unreasonable, direct, and substantial danger to the health of individuals presented by a device can be corrected or eliminated by labeling or a change in labeling, or change in advertising if the device is a restricted device, the Commissioner will provide written notice to the manufacturer, distributor, importer, or any other person(s) responsible for the labeling or advertising of the device specifying:

(1) The deception or risk of illness or injury or the danger to the health of individuals,

(2) The labeling or change in labeling, or change in advertising if the device is a restricted device, necessary to correct the deception or eliminate or reduce such risk or danger, and

(3) The period of time within which the labeling, change in labeling, or change in advertising must be accomplished.

(b) In specifying the labeling or change in labeling or change in advertising to correct the deception or to eliminate or reduce the risk of illness or injury or the danger to the health of individuals, the Commissioner may require the manufacturer, distributor, importer, or any other person(s) responsible for the labeling or advertising of the device to include in labeling for the device, and in advertising if the device is a restricted device, a statement, notice, or warning. Such statement, notice, or warning shall be in the manner and form prescribed by the Commissioner and shall identify the deception or risk of illness or injury or the unreasonable, direct, and substantial danger to the health of individuals associated with the device as previously labeled. Such statement, notice, or warning shall be used in the labeling and advertising of the device for a time period specified by the Commissioner on the basis of the degree of deception, risk of illness or injury, or danger to health; the frequency of sale of the device; the length of time the device has been on the market; the intended uses of the device; the method of its use; and any other factors that the Commissioner considers pertinent.

(c) The Commissioner will allow a manufacturer, distributor, importer, or any other person(s) responsible for the labeling or advertising of the device a reasonable time, considering the deception or risk of illness or injury or the danger to the health of individuals presented by the device, within which to accomplish the required labeling, change in labeling, and, if the device is a restricted device, any change in advertising. The Commissioner may, however, request that no additional devices be introduced into commerce until the labeling or change in labeling, or change in advertising is accomplished by the manufacturer, distributor, importer, or other person(s) responsible for the labeling or advertising of the device.

(d) If such voluntary action is not taken, the Commissioner may take action under other sections of the act to prevent the introduction of the devices into commerce. The Commissioner may consider the failure of a manufacturer, distributor, importer, or any other person(s) responsible for the labeling or advertising of the device to accomplish the required labeling or change in labeling, or change in advertising in accordance with this section as a basis for initiating a proceeding to make a device a banned device in accordance with § 895.21(d) and when appropriate to establish a special effective date in accordance with § 895.30.

(a) The Commissioner may declare a proposed regulation under § 895.21(d) to be effective upon its publication in the Federal Register and until the effective date of any final action taken respecting the regulation if:

(1) The Commissioner determines, on the basis of all available data and information, that the deception or risk of illness or injury associated with use of the device that is subject to the regulation presents an unreasonable, direct, and substantial danger to the health of individuals, and

(2) Before the date of the publication of such regulation, the Commissioner notifies the domestic manufacturer and importer, if any, of the device that the regulation is to be made so effective. If necessary, the Commissioner may also notify the distributor or any other responsible person(s). In addition, the Commissioner will attempt to notify any foreign manufacturer when the name and address of the foreign manufacturer are readily available.

(b) This procedure may be used when the Commissioner determines that the potential or actual injury involved is a serious one that the Commissioner believes will endanger the health of individuals who have been, or will be, exposed to the device. In assessing the degree of danger, the Commissioner need not find that the danger is immediate, and it shall be sufficient for the Commissioner to determine that the danger may involve a serious long-term risk.

(c) If the Commissioner makes a proposed regulation effective in accordance with this section, the Commissioner will, as expeditiously as possible, give interested persons prompt notice of this action in the Federal Register and will provide an opportunity for an informal hearing in accordance with part 16 of this chapter.

(d) After the hearing, if any, and after considering any written comments submitted on the proposal and any additional available information and data, the Commissioner will as expeditiously as possible either affirm, modify, or revoke the proposed regulation making the device a banned device. If the Commissioner decides to affirm or modify the proposed regulation to make a device a banned device, the Commissioner will amend subpart B by adding the name or description of the device, or both, to the list of banned devices. If the Commissioner decides to revoke a proposed regulation making a device a banned device, a notice of termination of rulemaking proceedings and reasons therefor will be published in the Federal Register.

(e) The Commissioner may declare the special effective date provided by this section to be in effect after the publication of a proposed regulation under § 895.21(d), if, based on new information, or upon reconsideration of previously available information, the Commissioner makes the determination and provides the appropriate notices and an opportunity for a hearing in accordance with paragraphs (a) and (c) of this section.

(f) Those devices that have been named banned devices under § 895.30 and that have already been sold to the public may be subject to relabeling by the manufacturer, distributor, importer, or any other person(s) responsible for the labeling of the device or may be subject to the provisions of section 518(a) or (b) of the act.