[Federal Register Volume 69, Number 249 (Wednesday, December 29, 2004)]
[Notices]
[Pages 78038-78039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28438]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket N0. 2003D-0568]


Guidance for Industry and FDA Staff; Class II Special Controls 
Guidance Document: Vascular and Neurovascular Embolization Devices; 
Availability

AGENCY: Food and Drug Administration, HHS

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance document entitled ``Class II Special 
Controls Guidance Document: Vascular and Neurovascular Embolization 
Devices.'' Elsewhere in this issue of the Federal Register, FDA is 
publishing a final rule to change the names, revise the 
identifications, and reclassify the two devices from class III 
(premarket approval) into class II (special controls). This guidance 
document describes a means by which the vascular embolization device 
and the neurovascular embolization device may comply with the 
requirement of special controls for class II devices. We are also 
announcing the withdrawal of the 1994 draft guidance document entitled 
``Guidance on Biocompatibility Requirements for Long Term Neurological 
Implants: Part 3--Implant Model,'' dated September 12, 1994.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance on 
a 3.5'' diskette of the guidance entitled ``Class II Special Controls 
Guidance Document: Vascular and Neurovascular Embolization Devices'' to 
the Division of Small Manufacturers, International, and Consumer 
Assistance (DSMICA) (HFZ-220), Center for Devices and Radiological 
Health (CDRH) (HFZ-220), Food and Drug Administration, 1350 Piccard 
Dr., Rockville, MD 20850. Send a self-addressed adhesive label to 
assist that office in processing your request, or fax your request to 
301-442-8818. See the SUPPLEMENTARY INFORMATION section for information 
on electronic access to the guidance.

[[Page 78039]]

    Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Peter L. Hudson, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-3090.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 25, 2004 (69 FR 8667), FDA 
published a proposed rule to reclassify two embolization devices from 
class III (premarket approval) into class II (special controls). The 
agency is also changing the names and revising the identifications of 
these devices. The vascular embolization device (previously the 
arterial embolization device) is intended to control hemorrhaging due 
to aneurysms, certain types of tumors, and arteriovenous malformations. 
The neurovascular embolization device (previously the artificial 
embolization device) is intended to permanently occlude blood flow to 
cerebral aneurysms and cerebral arteriovenous malformations.
    FDA revised a November 1, 2002, guidance document entitled 
``Guidance for Neurological Embolization Devices'' and published it in 
the Federal Register of February 25, 2004 (69 FR 9667) as a draft class 
II special controls guidance document to support the reclassification 
of these device types. Interested persons were invited to comment on 
the draft guidance by May 25, 2004. FDA received one comment. The 
comment was supportive of the guidance document but made some 
suggestions on the guidance's content. FDA considered the suggestions 
and made appropriate revisions. FDA is now identifying the guidance 
document entitled ``Class II Special Controls Guidance Document: 
Vascular and Neurovascular Embolization Devices'' as the guidance 
document that will serve as the special control for these devices.
    The guidance document provides a means by which a vascular 
embolization device or a neurovascular embolization device may comply 
with the requirement of special controls for class II devices. 
Following the effective date of the final reclassification rule, any 
firm submitting a premarket notification (510(k)) for a vascular 
embolization device or a neurovascular embolization device will need to 
address the issues covered in the special controls guidance document. 
However, the firm need only show that its device meets the 
recommendations of the guidance document or in some other way provides 
equivalent assurances of safety and effectiveness.
    We are also withdrawing the draft guidance document entitled 
``Guidance on Biocompatibility Requirements for Long Term Neurological 
Implants: Part 3--Implant Model'' because it contains outdated 
information. Archived copies of CDRH guidance documents that have been 
withdrawn are available from the DSMICA (see ADDRESSES).

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on vascular and neurovascular embolization 
devices. It does not create or confer any rights for or on any person 
and does not operate to bind FDA or the public. An alternative approach 
may be used if the approach satisfies the requirements of the 
applicable statute and regulations.

III. Electronic Access

    To receive a copy of the guidance entitled ``Class II Special 
Controls Guidance Document: Vascular and Neurovascular Embolization 
Devices'' by fax machine, call the CDRH Facts-On-Demand system at 800-
899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter 
the system. At the second voice prompt press 1 to order a document. 
Enter the document number (1234) followed by the pound sign 
(<greek-i>). Follow the remaining voice prompts to complete your 
request.
    Persons interested in obtaining a copy of the guidance also 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 Internet access. Updated on a 
regular basis, the CDRH home page includes device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturer's assistance, information on video 
conferencing and electronic submissions, Mammography Matters, and other 
device-oriented information. The CDRH Web site may be accessed at 
http://www.fda.gov.cdrh. A search capability for all CDRH guidance 
documents is available at http://www/fda/gov/cdrh/guidance.html.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (the PRA). 
The collections of information addressed in the guidance document have 
been approved by OMB in accordance with the PRA under the regulations 
governing 510(k) submissions (21 CFR part 807, subpart E, OMB control 
number 0910-0120) and the regulations governing good manufacturing 
practices (quality system regulation) (21 CFR part 820, OMB control 
number 0910-0073). The labeling provisions addressed in the guidance 
document have been approved by OMB under the PRA, OMB control number 
0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Comments received may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: December 15, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-28438 Filed 12-28-04; 8:45 am]
BILLING CODE 4160-01-S