[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: 21CFR810.12]

[Page 93-94]
 
                        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. 810.12  Written request for review of cease distribution and notification order.

    (a) In lieu of requesting a regulatory hearing under Sec. 810.11, 
the person named in a cease distribution and notification order may 
submit a written request to FDA asking that the order be modified or 
vacated. Such person shall address the written request to the agency 
employee identified in the order and shall submit the request within the 
timeframe specified in the order, unless FDA and the person named in the 
order agree to a later date.
    (b) A written request for review of a cease distribution and 
notification

[[Page 94]]

order shall identify each ground upon which the requestor relies in 
asking that the order be modified or vacated, as well as addressing an 
appropriate cease distribution and notification strategy, and shall 
address whether the order should be amended to require a recall of the 
device that was the subject of the order and the actions required by 
such a recall order, including an appropriate recall strategy.
    (c) The agency official who issued the cease distribution and 
notification order shall provide the requestor written notification of 
the agency's decision to affirm, modify, or vacate the order or amend 
the order to require a recall of the device within 15 working days of 
receipt of the written request. The agency official shall include in 
this written notification:
    (1) A statement of the grounds for the decision to affirm, modify, 
vacate, or amend the order; and
    (2) The requirements of any modified or amended order.