04-8022. 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.

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 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:

§ 807.22

[Corrected]

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

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

§ 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 § 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 § 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.