[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