Title 21

SECTION 810.15

810.15 Communications concerning a cease distribution and notification or mandatory recall order.

§ 810.15 Communications concerning a cease distribution and notification or mandatory recall order.

(a) General. The person named in a cease distribution and notification order issued under § 810.10 or a mandatory recall order issued under § 810.13 is responsible for promptly notifying each health professional, device user facility, consignee, or individual, as appropriate, of the order. In accordance with § 810.10(c) or § 810.13(b)(4), FDA may provide the person named in the cease distribution and notification or mandatory recall order with a model letter for notifying each health professional, device user facility, consignee, or individual, as appropriate, of the order. However, if FDA does not provide the person named in the cease distribution and notification or mandatory recall order with a model letter, the person named in a cease distribution and notification order issued under § 810.10, or a mandatory recall order issued under § 810.13, is responsible for providing such notification. The purpose of the communication is to convey:

(1) That FDA has found that there is a reasonable probability that use of the device would cause a serious, adverse health consequence or death;

(2) That the person named in the order has ceased distribution of the device;

(3) That health professionals and device user facilities should cease use of the device immediately;

(4) Where appropriate, that the device is subject to a mandatory recall order; and

(5) Specific instructions on what should be done with the device.

(b) Implementation. The person named in a cease distribution and notification order, or a mandatory recall order, shall notify the appropriate person(s) of the order by verified written communication, e.g., telegram, mailgram, or fax. The written communication and any envelope in which it is sent or enclosed shall be conspicuously marked, preferably in bold red ink: “URGENT - [DEVICE CEASE DISTRIBUTION AND NOTIFICATION ORDER] or [MANDATORY DEVICE RECALL ORDER].” Telephone calls or other personal contacts may be made in addition to, but not as a substitute for, the verified written communication, and shall be documented in an appropriate manner.

(c) Contents. The person named in the order shall ensure that the notice of a cease distribution and notification order or mandatory recall order:

(1) Is brief and to the point;

(2) Identifies clearly the device, size, lot number(s), code(s), or serial number(s), and any other pertinent descriptive information to facilitate accurate and immediate identification of the device;

(3) Explains concisely the serious, adverse health consequences that may occur if use of the device were continued;

(4) Provides specific instructions on what should be done with the device;

(5) Provides a ready means for the recipient of the communication to confirm receipt of the communication and to notify the person named in the order of the actions taken in response to the communication. Such means may include, but are not limited to, the return of a postage-paid, self-addressed post card or a toll-free call to the person named in the order; and

(6) Does not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message.

(d) Followup communications. The person named in the cease distribution and notification order or mandatory recall order shall ensure that followup communications are sent to all who fail to respond to the initial communication.

(e) Responsibility of the recipient. Health professionals, device user facilities, and consignees who receive a communication concerning a cease distribution and notification order or a mandatory recall order should immediately follow the instructions set forth in the communication. Where appropriate, these recipients should immediately notify their consignees of the order in accordance with paragraphs (b) and (c) of this section.

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