[Federal Register Volume 65, Number 76 (Wednesday, April 19, 2000)]
[Notices]
[Pages 20995-20996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9710]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 00D-1086, 00D-1087, 00D-1088, 00D-1089, 00D-1090, and 00D-
1091]


Guidance Documents for Premarket Notification (510(k)) 
Submissions for Six Devices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of six guidance documents. These six guidance documents 
are intended to serve as special controls for six devices that FDA has 
proposed previously to reclassify from class III (premarket approval) 
to class II (special controls). Elsewhere in this issue of the Federal 
Register, FDA is reopening the comment period on the proposed 
reclassification of the six devices and one other device. FDA is now 
inviting comment on these guidance documents because they were not 
available for comment at the time of the publication of the proposed 
reclassification (64 FR 12774, March 15, 1999).

DATES: Submit written comments 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. Comments should be identified with the docket 
number for the appropriate guidance document found in the SUPPLEMENTARY 
INFORMATION section. Submit written requests for single copies on a 
3.5" diskette of one or more of these guidance documents to the 
Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health, Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
labels to assist that office in processing your request, or fax your 
request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance documents.

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, FDA published a proposed 
rule to reclassify 38 preamendments class III devices into class II and 
to establish special controls for these devices. FDA invited interested 
persons to comment on the proposed rule by June 14, 1999.
    FDA received one request to reopen the comment period for six 
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 FDA's Good Guidance Practices (GGP's) (62 FR 8961, 
February 27, 1997). The request further noted that it was impossible to 
comment on the proposed reclassification without the guidance documents 
being available. Therefore, the requester asked that FDA extend the 
comment period until at least 90 days after the guidance documents are 
publicly available. FDA agreed with the request. FDA also identified 
three additional devices for which the agency had not issued the 
guidance documents proposed as special controls in accordance with the 
GGP policy.
    The agency is announcing the availability of the following six 
guidance documents (each with a separate docket number) for six of 
these nine devices. In the near future, FDA will announce the 
availability of two guidance documents that will address the other 
three devices.
    The six guidance documents, with their docket numbers, and Facts-
on-Demand (FOD) numbers are as follows:

 
------------------------------------------------------------------------
                     Docket
Guidance document     No.      FOD No.  21 CFR Section     Device name
------------------------------------------------------------------------
Guidance for the   00D-1086   372           870.3260    Pacemaker lead
 Submission of                                           adaptor.
 Research and
 Marketing
 Applications for
 Permanent
 Pacemaker Leads
 and for
 Pacemaker Lead
 Adaptor 510(k)
 Submissions.
Guidance Document  00D-1087   1357          870.3450    Vascular graft
 for Vascular                                            prosthesis of
 Prostheses                                              less than 6
 510(k)                                                  millimeter
 Submissions.                                            diameter.
Guidance for       00D-1088   1358          870.3800    Annuloplasty
 Annuloplasty                                            ring.
 Rings 510(k)
 Submissions.
Guidance for       00D-1089   1632          870.4230    Cardiopulmonary
 Extracorporeal                                          bypass
 Blood Circuit                                           defoamer.
 Defoamer 510(k)
 Submissions.
Guidance for       00D-1090   1622          870.4260    Cardiopulmonary
 Cardiopulmonary                                         bypass arterial
 Bypass Arterial                                         line blood
 Line Blood                                              filter.
 Filter 510(k)
 Submissions.
Guidance for       00D-1091   1361          870.4360    Cardiopulmonary
 Cardiopulmonary                                         bypass
 Bypass                                                  oxygenators.
 Oxygenators
 510(k)
 Submissions.
------------------------------------------------------------------------

    These guidance documents represent the agency's current thinking on 
premarket notifications for these devices. These guidance documents do 
not create or confer any rights for or on any person and do not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the applicable statute, regulations, or both. Under 
FDA's GGP policy, each of these guidance documents is a Level 2 
guidance.

[[Page 20996]]

II. Electronic Access

    In order to receive these guidance documents via your fax machine, 
call the CDRH FOD system at 800-899-0381 or 301-827-0111 from a touch-
tone telephone. Press 1 to enter the system and enter the document 
number listed above followed by the pound sign (#). Follow the 
remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of these guidance documents 
may do so by using the Internet. CDRH maintains an entry on the 
Internet for easy access to information including text, graphics, and 
files that may be downloaded to a personal computer with access to the 
Internet. Updated on a regular basis, the CDRH home page includes these 
guidance documents, device safety alerts, Federal Register reprints, 
information on premarket submissions (including lists of approved 
applications and manufacturers' addresses), small manufacturers' 
assistance, information on video conferencing and electronic 
submissions, mammography matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh. These guidance documents are also available at http://www.fda.gov/cdrh/ODE.

III. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding these guidance documents 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 for each guidance document as listed in the 
table in the SUPPLEMENTARY INFORMATION section of this document. If you 
wish to comment on more than one guidance document, please submit your 
comments separately for each guidance document. The guidance documents 
and received comments may be seen in the Dockets Management Branch 
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. 00-9710 Filed 4-18-00; 8:45 am]
BILLING CODE 4160-01-F