[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR810.14]

[Page 102-103]
 
                        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. 810.14  Cease distribution and notification or mandatory
recall strategy.

    (a) General. The person named in a cease distribution and 
notification order issued under Sec. 810.10 shall comply with the 
order, which FDA will fashion as appropriate for the individual 
circumstances of the case. The person named in a cease distribution and 
notification order modified under Sec. 810.11(e) or Sec. 810.12(c) or 
a mandatory recall order issued under Sec. 810.13 shall develop a 
strategy for complying with the order that is appropriate for the 
individual circumstances and that takes into account the following 
factors:
    (1) The nature of the serious, adverse health consequences related 
to the device;
    (2) The ease of identifying the device;
    (3) The extent to which the risk presented by the device is obvious 
to a health professional or device user facility; and
    (4) The extent to which the device is used by health professionals 
and device user facilities.
    (b) Submission and review. (1) The person named in the cease 
distribution and notification order modified under Sec. 810.11(e) or 
Sec. 810.12(c) or mandatory recall order shall submit a copy of the 
proposed strategy to the agency within the timeframe specified in the 
order.
    (2) The agency will review the proposed strategy and make any 
changes to the strategy that it deems necessary within 7 working days of 
receipt of the proposed strategy. The person named in the order shall 
act in accordance with a strategy determined by FDA to be appropriate.
    (c) Elements of the strategy. A proposed strategy shall meet all of 
the following requirements:

[[Page 103]]

    (1)(i) The person named in the order shall specify the level in the 
chain of distribution to which the cease distribution and notification 
order or mandatory recall order is to extend as follows:
    (A) Consumer or user level, e.g., health professionals, consignee, 
or device user facility level, including any intermediate wholesale or 
retail level; or
    (B) Retail level, to the level immediately preceding the consumer or 
user level, and including any intermediate level; or
    (C) Wholesale level.
    (ii) The person named in the order shall not recall a device from 
individuals; and
    (iii) The person named in the order shall not recall a device from 
device user facilities if FDA notifies the person not to do so because 
of a risk determination under Sec. 810.13(c)(2).
    (2) The person named in a recall order shall ensure that the 
strategy provides for notice to individuals subject to the risks 
associated with use of the recalled device. The notice may be provided 
through the individuals' health professionals if FDA determines that 
such consultation is appropriate and would be the most effective method 
of notifying patients.
    (3) Effectiveness checks by the person named in the order are 
required to verify that all health professionals, device user 
facilities, consignees, and individuals, as appropriate, have been 
notified of the cease distribution and notification order or mandatory 
recall order and of the need to take appropriate action. The person 
named in the cease distribution and notification order or the mandatory 
recall order shall specify in the strategy the method(s) to be used in 
addition to written communications as required by Sec. 810.15, i.e., 
personal visits, telephone calls, or a combination thereof to contact 
all health professionals, device user facilities, consignees, and 
individuals, as appropriate. The agency may conduct additional audit 
checks where appropriate.