[Federal Register: December 29, 2004 (Volume 69, Number 249)]
[Notices]
[Page 78038-78039]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29de04-120]
-----------------------------------------------------------------------
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announcing the withdrawal of the 1994 draft guidance document entitled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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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
(). 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov.cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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