§895.30. Special effective date. — Inbound Citations

(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.

(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.

(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.

(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.

(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.