[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR810.16]

[Page 96-97]
 
                        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. 810.16  Cease distribution and notification or mandatory recall order status reports.

    (a) 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 shall submit periodic status reports to FDA to enable the 
agency to assess the person's progress in complying with the order. The 
frequency of such reports and the agency official to whom such reports 
shall be submitted will be specified in the order.
    (b) Unless otherwise specified in the order, each status report 
shall contain the following information:
    (1) The number and type of health professionals, device user 
facilities, consignees, or individuals notified about the order and the 
date and method of notification;
    (2) The number and type of health professionals, device user 
facilities, consignees, or individuals who have responded to the 
communication and the quantity of the device on hand at these locations 
at the time they received the communication;
    (3) The number and type of health professionals, device user 
facilities, consignees, or individuals who have not responded to the 
communication;
    (4) The number of devices returned or corrected by each health 
professional, device user facility, consignee, or individual contacted, 
and the quantity of products accounted for;
    (5) The number and results of effectiveness checks that have been 
made; and

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    (6) Estimated timeframes for completion of the requirements of the 
cease distribution and notification order or mandatory recall order.
    (c) The person named in the cease distribution and notification 
order or recall order may discontinue the submission of status reports 
when the agency terminates the order in accordance with Sec. 810.17.