[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR810.10]

[Page 91-92]
 
                        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. 810.10  Cease distribution and notification order.


    (a) If, after providing the appropriate person with an opportunity 
to consult with the agency, FDA finds that there is a reasonable 
probability that a device intended for human use would

[[Page 92]]

cause serious, adverse health consequences or death, the agency may 
issue a cease distribution and notification order requiring the person 
named in the order to immediately:
    (1) Cease distribution of the device;
    (2) Notify health professionals and device user facilities of the 
order; and
    (3) Instruct these professionals and device user facilities to cease 
use of the device.
    (b) FDA will include the following information in the order:
    (1) The requirements of the order relating to cessation of 
distribution and notification of health professionals and device user 
facilities;
    (2) Pertinent descriptive information to enable accurate and 
immediate identification of the device subject to the order, including, 
where known:
    (i) The brand name of the device;
    (ii) The common name, classification name, or usual name of the 
device;
    (iii) The model, catalog, or product code numbers of the device; and
    (iv) The manufacturing lot numbers or serial numbers of the device 
or other identification numbers; and
    (3) A statement of the grounds for FDA's finding that there is a 
reasonable probability that the device would cause serious, adverse 
health consequences or death.
    (c) FDA may also include in the order a model letter for notifying 
health professionals and device user facilities of the order and a 
requirement that notification of health professionals and device user 
facilities be completed within a specified timeframe. The model letter 
will include the key elements of information that the agency in its 
discretion has determined, based on the circumstances surrounding the 
issuance of each order, are necessary to inform health professionals and 
device user facilities about the order.
    (d) FDA may also require that the person named in the cease 
distribution and notification order submit any or all of the following 
information to the agency by a time specified in the order:
    (1) The total number of units of the device produced and the 
timespan of the production;
    (2) The total number of units of the device estimated to be in 
distribution channels;
    (3) The total number of units of the device estimated to be 
distributed to health professionals and device user facilities;
    (4) The total number of units of the device estimated to be in the 
hands of home users;
    (5) Distribution information, including the names and addresses of 
all consignees;
    (6) A copy of any written communication used by the person named in 
the order to notify health professionals and device user facilities;
    (7) A proposed strategy for complying with the cease distribution 
and notification order;
    (8) Progress reports to be made at specified intervals, showing the 
names and addresses of health professionals and device user facilities 
that have been notified, names of specific individuals contacted within 
device user facilities, and the dates of such contacts; and
    (9) The name, address, and telephone number of the person who should 
be contacted concerning implementation of the order.
    (e) FDA will provide the person named in a cease distribution and 
notification order with an opportunity for a regulatory hearing on the 
actions required by the cease distribution and notification order and on 
whether the order should be modified, or vacated, or amended to require 
a mandatory recall of the device.
    (f) FDA will also provide the person named in the cease distribution 
and notification order with an opportunity, in lieu of a regulatory 
hearing, to submit a written request to FDA asking that the order be 
modified, or vacated, or amended.
    (g) FDA will include in the cease distribution and notification 
order the name, address, and telephone number of an agency employee to 
whom any request for a regulatory hearing or agency review is to be 
addressed.