[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR810.15]

[Page 95-96]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 810--MEDICAL DEVICE RECALL AUTHORITY--Table of Contents
 
          Subpart B--Mandatory Medical Device Recall Procedures
 
Sec. 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 Sec. 810.10 or a mandatory recall order 
issued under Sec. 810.13 is responsible for promptly notifying each 
health professional, device user facility, consignee, or individual, as 
appropriate, of the order. In accordance with Sec. 810.10(c) or 
Sec. 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 
Sec. 810.10, or a mandatory recall order issued under Sec. 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;

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    (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.