[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR807.31]

[Page 64-65]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES--Table of Contents
 
             Subpart B--Procedures for Device Establishments
 
Sec. 807.31  Additional listing information.

    (a) Each owner or operator shall maintain a historical file 
containing

[[Page 65]]

the labeling and advertisements in use on the date of initial listing, 
and in use after October 10, 1978, but before the date of initial 
listing, as follows:
    (1) For each device subject to section 514 or 515 of the act that is 
not a restricted device, a copy of all labeling for the device;
    (2) For each restricted device, a copy of all labeling and 
advertisements for the device;
    (3) For each device that is neither restricted nor subject to 
section 514 or 515 of the act, a copy of all labels, package inserts, 
and a representative sampling of any other labeling.
    (b) In addition to the requirements set forth in paragraph (a) of 
this section, each owner or operator shall maintain in the historical 
file any labeling or advertisements in which a material change has been 
made anytime after initial listing.
    (c) Each owner or operator may discard labeling and advertisements 
from the historical file 3 years after the date of the last shipment of 
a discontinued device by an owner or operator.
    (d) Location of the file:
    (1) Currently existing systems for maintenance of labeling and 
advertising may be used for the purpose of maintaining the historical 
file as long as the information included in the systems fulfills the 
requirements of this section, but only if the labeling and 
advertisements are retrievable in a timely manner.
    (2) The contents of the historical file may be physically located in 
more than one place in the establishment or in more than one 
establishment provided there exists joint ownership and control among 
all the establishments maintaining the historical file. If no joint 
ownership and control exists, the registered establishment must provide 
the Food and Drug Administration with a letter authorizing the 
establishment outside its control to maintain the historical file.
    (3) A copy of the certification and disclosure statements as 
required by part 54 of this chapter shall be retained and physically 
located at the establishment maintaining the historical file.
    (e) Each owner or operator shall be prepared to submit to the Food 
and Drug Administration, only upon specific request, the following 
information:
    (1) For a device subject to section 514 or 515 of the act that is 
not a restricted device, a copy of all labeling for the device.
    (2) For a device that is a restricted device, a copy of all labeling 
for the device, a representative sampling of advertisements for the 
device, and for good cause, a copy of all advertisements for a 
particular device. A request for all advertisements will, where 
feasible, be accompanied by an explanation of the basis for such 
request.
    (3) For a device that is neither a restricted device, nor subject to 
section 514 of 515 of the act, the label and package insert for the 
device and a representative sampling of any other labeling for the 
device.
    (4) For a particular device, a statement of the basis upon which the 
registrant has determined that the device is not subject to section 514 
or 515 of the act.
    (5) For a particular device, a statement of the basis upon which the 
registrant has determined the device is not a restricted device.
    (6) For a particular device, a statement of the basis for 
determining that the product is a device rather than a drug.
    (7) For a device that the owner or operator has manufactured for 
distribution under a label other than its own, the names of all 
distributors for whom it has been manufactured.

[43 FR 37999, Aug. 25, 1978, as amended at 51 FR 33033, Sept. 18, 1986; 
63 FR 5253, Feb. 2, 1998]