[Federal Register Volume 65, Number 76 (Wednesday, April 19, 2000)]
[Proposed Rules]
[Pages 20933-20934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9709]


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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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SUMMARY: The Food and Drug Administration (FDA) is reopening for 90 
days the comment period for the submission of comments regarding 6 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 part in 
response to a request for more time to submit comments to FDA regarding 
several of 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 of these 
guidance documents for comment.

DATES: Submit written comments on the proposed rule by July 18, 2000.

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 the following six devices: (1) Vascular graft prosthesis of less 
than 6 millimeters diameter, (2) pacemaker lead adaptor, (3) 
annuloplasty ring, (4) cardiopulmonary bypass defoamer, (5) 
cardiopulmonary bypass arterial line blood filter, and (6) 
cardiopulmomonary bypass oxygenator. 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 are publicly available for comment.
    FDA also identified an additional three devices for which the 
agency had

[[Page 20934]]

not issued the guidance documents proposed as special controls in 
accordance with the GGP policy: The indwelling blood carbon dioxide 
partial pressure (Pco<SUP>2</SUP>) analyzer, the indwelling blood 
hydrogen ion concentration (pH) analyzer, and the indwelling blood 
oxygen partial pressure (Po<SUP>2</SUP>) analyzer. In the near future, 
FDA intends to announce the availability of two guidance documents for 
these three devices and will reopen the comment period on the 
reclassification of those devices at that time.
    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 six devices:

                                 Table 1
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           21 CFR Section                        Device Name
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870.3450                             Vascular graft prosthesis of less
                                      than 6 millimeters diameter
870.3620                             Pacemaker lead adaptor
870.3800                             Annuloplasty ring
870.4230                             Cardiopulmonary bypass defoamer
870.4260                             Cardiopulmonary bypass arterial
                                      line blood filter
870.4350                             Cardiopulmonary bypass oxygenator
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II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding the proposed rule only with 
respect to the six devices listed above by July 18, 2000. 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 may be seen 
in the office above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 3, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-9709 Filed 4-18-00; 8:45 am]
BILLING CODE 4160-01-F