[Federal Register Volume 65, Number 226 (Wednesday, November 22, 2000)]
[Proposed Rules]
[Pages 70325-70326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29839]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 864, 866, 868, 870, 872, 874, 876, 878, 884, 886, and 
888

[Docket No. 99N-0035]


Medical Devices; Reclassification of 38 Preamendments Class III 
Devices into Class II

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

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[[Page 70326]]

SUMMARY: The Food and Drug Administration (FDA) is reopening for 90 
days the comment period for the submission of comments regarding 3 of 
the 38 devices proposed for reclassification from class III into class 
II. The proposed rule was published in the Federal Register of March 
15, 1999 (64 FR 12774). The agency is taking this action in order to 
allow more time to submit comments to FDA regarding the guidance 
documents that were not made available when the March 15, 1999, 
proposed rule was published. Elsewhere in this issue of the Federal 
Register, FDA is announcing the availability for comment of two 
guidance documents that are special controls for three devices.

DATES: Submit written comments on the proposed rule by February 20, 
2001.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-827-2974.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 15, 1999 (64 FR 12774), FDA 
published a proposed rule to reclassify 38 preamendments class III 
devices into class II and to establish special controls for these 
devices. Interested persons were given until June 14, 1999, to comment 
on the proposed rule.
    A trade association requested that FDA reopen the comment period 
for 6 of the 38 devices. The request noted that FDA had not made the 
guidance documents that were proposed as special controls for these six 
devices available for comment through the agency's good guidance 
practices (GGP's). The request further noted that it was impossible to 
comment on the proposed reclassification without the guidance documents 
being available. Therefore, the trade association requested that FDA 
extend the comment period until at least 90 days after the guidance 
documents became publicly available for comment. In the Federal 
Register of April 19, 2000 (65 FR 20933), FDA reopened the comment 
period on the proposed reclassification of those six devices.
    FDA also identified an additional three devices for which the 
agency had not issued the guidance documents proposed as special 
controls for comment in accordance with the GGP policy. Elsewhere in 
this issue of the Federal Register, FDA is announcing the availability 
for comment of two guidance documents that are special controls for 
three devices. Accordingly, FDA is reopening the comment period for the 
March 15, 1999, proposed rule to allow additional time for interested 
persons to comment on the following three devices:
    <bullet> Indwelling blood carbon dioxide partial pressure 
(P<INF>co2</INF>) analyzer (21 CFR 868.1150),
    <bullet> Indwelling blood hydrogen ion concentration (pH) analyzer 
(21 CFR 868.1170), and
    <bullet> Indwelling blood oxygen partial pressure (P<INF>o2</INF>) 
analyzer (21 CFR 868.1200).

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding the proposed rule only with 
respect to the three devices listed above by February 20, 2001. Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. Received comments 
are available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 31, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-29839 Filed 11-21-00; 8:45 am]
BILLING CODE 4160-01-F