[Federal Register Volume 69, Number 68 (Thursday, April 8, 2004)]
[Rules and Regulations]
[Pages 18472-18473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8022]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 807


Medical Device Reports; Reports of Corrections and Removals; 
Establishment Registration and Device Listing: Premarket Approval 
Supplements; Quality System Regulation; Importation of Electronic 
Products; Technical Amendment; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule that appeared in the Federal Register of March 10, 2004 (69 FR 
11310). That document corrected some inadvertent typographical errors 
and some technical errors. That document published with an inadvertent 
error. This document corrects that error.

EFFECTIVE DATE: April 8, 2004.

FOR FURTHER INFORMATION CONTACT: Joyce A. Strong, Office of Policy and 
Planning (HF-27), Food and Drug

[[Page 18473]]

Administration, Piccard Dr., Rockville, MD 20857, 301-827-7010.

SUPPLEMENTARY INFORMATION: In FR Doc. 04-5302, appearing on page 11310 
in the Federal Register of Wednesday, March 10, 2004, the following 
correction is made:


Sec.  807.22  [Corrected]

    On page 11311, in the third column, in part 807, amendatory 
instruction no. 6 is corrected to read as follows:

0
``6. Section 807.22 is amended by revising paragraphs (a) and (b) to 
read as follows:


Sec.  807.22  How and where to register establishments and list 
devices.

    (a) The first registration of a device establishment shall be on 
Form FDA-2801 (Initial Registration of Device Establishment). Forms are 
available upon request from the Office of Compliance, Center for 
Devices and Radiological Health (HFZ-308), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850-4015, or from 
Food and Drug Administration district offices. Subsequent annual 
registration shall be accomplished on Form FDA-2891a (Annual 
Registration of Device Establishment), which will be furnished by FDA 
to establishments whose registration for that year was validated under 
Sec.  807.35(a). The forms will be mailed to the owner or operators of 
all establishments via the official correspondent in accordance with 
the schedule as described in Sec.  807.21(a). The completed form shall 
be mailed to the address designated in this paragraph 30 days after 
receipt from FDA.
    (b) The initial listing of devices and subsequent June and December 
updatings shall be on form FDA-2892 (Medical Device Listing). Forms are 
obtainable upon request as described in paragraph (a) of this section. 
A separate form FDA-2892 shall be submitted for each device or device 
class listed with the Food and Drug Administration. Devices having 
variations in physical characteristics such as size, package, shape, 
color, or composition should be considered to be one device: Provided, 
The variation does not change the function or intended use of the 
device. In lieu of form FDA-2892, tapes for computer input or hard copy 
computer output may by submitted if equivalent in all elements of 
information as specified in form FDA-2892. All formats proposed for use 
in lieu of form FDA-2892 require initial review and approval by the 
Food and Drug Administration.''

    Dated: April 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-8022 Filed 4-7-04; 8:45 am]
BILLING CODE 4160-01-S