[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: 21CFR810.13]

[Page 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. 810.13  Mandatory recall order.

    (a) If the person named in a cease distribution and notification 
order does not request a regulatory hearing or submit a request for 
agency review of the order, or, if the Commissioner of Food and Drugs or 
the presiding officer denies a request for a hearing, or, if after 
conducting a regulatory hearing under Sec. 810.11 or completing agency 
review of a cease distribution and notification order under Sec. 810.12, 
FDA determines that the order should be amended to require a recall of 
the device with respect to which the order was issued, FDA shall amend 
the order to require such a recall. FDA shall amend the order to require 
such a recall within 15 working days of issuance of a cease distribution 
and notification order if a regulatory hearing or agency review of the 
order is not requested, or within 15 working days of denying a request 
for a hearing, or within 15 working days of completing a regulatory 
hearing under Sec. 810.11, or within 15 working days of receipt of a 
written request for review of a cease distribution and notification 
order under Sec. 810.12.
    (b) In a mandatory recall order, FDA may:
    (1) Specify that the recall is to extend to the wholesale, retail, 
or user level;
    (2) Specify a timetable in accordance with which the recall is to 
begin and be completed;
    (3) Require the person named in the order to submit to the agency a 
proposed recall strategy, as described in Sec. 810.14, and periodic 
reports describing the progress of the mandatory recall, as described in 
Sec. 810.16; and
    (4) Provide the person named in the order with a model recall 
notification letter that includes the key elements of information that 
FDA has determined are necessary to inform health professionals and 
device user facilities.
    (c) FDA will not include in a mandatory recall order a requirement 
for:
    (1) Recall of a device from individuals; or
    (2) Recall of a device from device user facilities, if FDA 
determines that the risk of recalling the device from the facilities 
presents a greater health risk than the health risk of not recalling the 
device from use, unless the device can be replaced immediately with an 
equivalent device.
    (d) FDA will include in a mandatory recall order provisions for 
notification to individuals subject to the risks associated with use of 
the device. If a significant number of such individuals cannot be 
identified, FDA may notify such individuals under section 705(b) of the 
act.