[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: 21CFR821.30]

[Page 163-164]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 821_MEDICAL DEVICE TRACKING REQUIREMENTS--Table of Contents
 
         Subpart C_Additional Requirements and Responsibilities
 
Sec. 821.30  Tracking obligations of persons other than device
manufacturers: distributor requirements.


    (a) A distributor, final distributor, or multiple distributor of any 
tracked device shall, upon purchasing or otherwise acquiring any 
interest in such a device, promptly provide the manufacturer tracking 
the device with the following information:
    (1) The name and address of the distributor, final distributor or 
multiple distributor;
    (2) The lot number, batch number, model number, or serial number of 
the device or other identifier used by the manufacturer to track the 
device;
    (3) The date the device was received;
    (4) The person from whom the device was received;
    (5) If and when applicable, the date the device was explanted, the 
date of the patient's death, or the date the device was returned to the 
distributor, permanently retired from use, or otherwise permanently 
disposed of.
    (b) A final distributor, upon sale or other distribution of a 
tracked device for use in or by the patient, shall promptly provide the 
manufacturer tracking the device with the following information:
    (1) The name and address of the final distributor,
    (2) The lot number, batch number, model number, or serial number of 
the device or other identifier used by the manufacturer to track the 
device;
    (3) The name, address, telephone number, and social security number 
(if available) of the patient receiving the device, unless not released 
by the patient under Sec. 821.55(a);
    (4) The date the device was provided to the patient or for use in 
the patient;
    (5) The name, mailing address, and telephone number of the 
prescribing physician;

[[Page 164]]

    (6) The name, mailing address, and telephone number of the physician 
regularly following the patient if different than the prescribing 
physician; and
    (7) When applicable, the date the device was explanted and the name, 
mailing address, and telephone number of the explanting physician, the 
date of the patient's death, or the date the device was returned to the 
manufacturer, permanently retired from use, or otherwise permanently 
disposed of.
    (c)(1) A multiple distributor shall keep written records of the 
following each time such device is distributed for use by a patient:
    (i) The lot number, batch number, or model number, or serial number 
of the device or other identifier used by the manufacturer to track the 
device;
    (ii) The name, address, telephone number, and social security number 
(if available) of the patient using the device;
    (iii) The location of the device, unless not released by the patient 
under Sec. 821.55(a);
    (iv) The date the device was provided for use by the patient;
    (v) The name, address, and telephone number of the prescribing 
physician;
    (vi) The name, address, and telephone number of the physician 
regularly following the patient if different than the prescribing 
physician; and
    (vii) When applicable, the date the device was permanently retired 
from use or otherwise permanently disposed of.
    (2) Except as required by order under section 518(e) of the act, any 
person who is a multiple distributor subject to the recordkeeping 
requirement of paragraph (c)(1) of this section shall, within 5 working 
days of a request from the manufacturer or within 10 working days of a 
request from FDA for the information identified in paragraph (c)(1) of 
this section, provide such information to the manufacturer or FDA.
    (d) A distributor, final distributor, or multiple distributor shall 
make any records required to be kept under this part available to the 
manufacturer of the tracked device for audit upon written request by an 
authorized representative of the manufacturer.
    (e) A distributor, final distributor, or multiple distributor may 
petition for an exemption or variance from one or more requirements of 
this part according to the procedures in Sec. 821.2.

[58 FR 43447, Aug. 16, 1993, as amended at 67 FR 5951, Feb. 8, 2002]