(a)General. The person named in a cease distribution and notification order issued under 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 810.11(e) or 810.12(c) or a mandatory recall order issued under 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 810.11(e) or 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:
(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 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 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.