[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR807.30]

[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 Domestic Device Establishments
 
Sec. 807.30  Updating device listing information.

    (a) Form FD-2892 shall be used to update device listing information. 
The preprinted original document number of each form FD-2892 on which 
the device was initially listed shall appear in block 2 on the form 
subsequently used to update the listing information for the device and 
on any correspondence related to the device.
    (b) An owner or operator shall update the device listing information 
during each June and December or, at its discretion, at the time the 
change occurs. Conditions that require updating and information to be 
submitted for each of these updates are as follows:
    (1) If an owner or operator introduces into commercial distribution 
a device identified with a classification name not currently listed by 
the owner or operator, then the owner or operator must submit form FD-
2892 containing all the information required by Sec. 807.25(f).
    (2) If an owner or operator discontinues commercial distribution of 
all devices in the same device class, i.e., with the same classification 
name, the owner or operator must submit form FD-2892 containing the 
original document number of the form FD-2892 on which the device class 
was initially listed, the reason for submission, the date of 
discontinuance, the owner or operator's name and identification number, 
the classification name and number, the proprietary name, and the common 
or usual name of the discontinued device.
    (3) If commercial distribution of a discontinued device identified 
on a form FD-2892 filed under paragraph (b)(2) of this section is 
resumed, the owner or operator must submit on form FD-2892 a notice of 
resumption containing: the original document number of the form 
initially used to list that device class, the reason for submission, 
date of resumption, and all other information required by 
Sec. 807.25(f).
    (4) If one or more classification names for a previously listed 
device with multiple classification names has been added or deleted, the 
owner or operator must supply the original document number from the form 
FD-2892 on which the device was initially listed and a supplemental 
sheet identifying the names of any new or deleted classification names.
    (5) Other changes to information on form FD-2892 will be updated as 
follows:
    (i) Whenever a change occurs only in the owner or operator name 
(block 6) or number (block 7), e.g., whenever one company's device line 
is purchased by another owner or operator, it will not be necessary to 
supply a separate form FD-2892 for each device. In such cases, the new 
owner or operator must follow the procedures in Sec. 807.26 and submit a 
letter informing the Food and Drug Administration of the original 
document number from form FD-2892 on which each device was initially 
listed for those devices affected by the change in ownership.
    (ii) The owner or operator must also submit update information 
whenever changes occur to the responses to the questions in blocks 12, 
12a, 13, 13a, and 14 on form FD-2892, or whenever establishment 
registration numbers, establishment names, and/or activities are added 
to or deleted from blocks 15, 16, and 17 of form FD-2892. The owner or 
operator must supply the original document number from the form FD-2892 
on which the device was initially listed, the reason for submission, and 
all other information required by Sec. 807.25(f).

[[Page 65]]

    (6) Updating is not required if the above information has not 
changed since the previously submitted list. Also, updating is not 
required if changes occur in proprietary names, in common or usual names 
(blocks 10 and 11 of form FD-2892), or to supplemental lists of 
unclassified components or accessories.

[43 FR 37998, Aug. 25, 1978]