[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: 21CFR810.17]

[Page 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. 810.17  Termination of a cease distribution and notification or mandatory recall order.

    (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 may request termination of the order by submitting a written 
request to FDA. The person submitting a request shall certify that he or 
she has complied in full with all of the requirements of the order and 
shall include a copy of the most current status report submitted to the 
agency under Sec. 810.16. A request for termination of a recall order 
shall include a description of the disposition of the recalled device.
    (b) FDA may terminate a cease distribution and notification order 
issued under Sec. 810.10 or a mandatory recall order issued under 
Sec. 810.13 when the agency determines that the person named in the 
order:
    (1) Has taken all reasonable efforts to ensure and to verify that 
all health professionals, device user facilities, consignees, and, where 
appropriate, individuals have been notified of the cease distribution 
and notification order, and to verify that they have been instructed to 
cease use of the device and to take other appropriate action; or
    (2) Has removed the device from the market or has corrected the 
device so that use of the device would not cause serious, adverse health 
consequences or death.
    (c) FDA will provide written notification to the person named in the 
order when a request for termination of a cease distribution and 
notification order or a mandatory recall order has been granted or 
denied. FDA will respond to a written request for termination of a cease 
distribution and notification or recall order within 30 working days of 
its receipt.