[Federal Register: February 25, 2004 (Volume 69, Number 37)]
[Notices]
[Page 8667-8668]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe04-77]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0568]
Draft Guidance for Industry and FDA Staff on Class II Special
Controls Guidance Document: Vascular and Neurovascular Embolization
Devices; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance for industry and FDA staff entitled
``Class II Special Controls Guidance Document: Vascular and
Neurovascular Embolization Devices.'' It was developed as a special
control to support the reclassification of the vascular embolization
device and the neurovascular embolization device from class III
(premarket approval) into class II (special controls). The draft
guidance is not final nor is it in effect at this time. 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announcing the withdrawal of the 1994 draft guidance document entitled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DATES: Submit written or electronic comments on the draft guidance by
May 25, 2004.
ADDRESSES: Submit written requests for single copies of the draft
guidance on a 3.5'' diskette to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health (HFZ-220), 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. Submit written comments on the draft guidance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. See
the SUPPLEMENTARY INFORMATION section for information on electronic
access to the draft guidance document.
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
FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled ``Class II Special Controls Guidance Document:
Vascular and Neurovascular Embolization Devices.''
On June 12, 1998, the Neurological Devices Panel (the Panel)
considered the information in three submissions of safety and
effectiveness under section 515(i) for the neurovascular embolization
device, and recommended that this device be reclassified from class III
into class II.
While the Panel's recommendation was specifically for the
neurovascular embolization device, because of the similarity of the
vascular (arterial) embolization device to the neurovascular
(artificial) embolization device, with regard to its intended use,
design, risks to health, and measures to mitigate the risks to health,
FDA determined that the Panel reclassification recommendation for the
neurovascular embolization device is relevant to the vascular
embolization device.
We are withdrawing the guidance document entitled ``Guidance on
Biocompatibility Requirements for Long Term Neurological Implants: Part
3--Implant Model'' because it contains outdated information. Archived
copies of Center for Devices and Radiological Health (CDRH) guidance
documents that have been withdrawn are available from the Division of
Small Manufacturers, International, and Consumer Assistance (see
ADDRESSES).
Elsewhere in this issue of the Federal Register, FDA is proposing
to reclassify the vascular embolization device and the neurovascular
embolization device into class II. The currently available guidance
document entitled ``Guidance for Neurological Embolization Devices''
dated November 1, 2000, was revised as a draft class II special
controls guidance document to support the reclassification of these
device types. If finalized, the ``Class II Special Controls Guidance
Document: Vascular and Neurovascular Embolization Devices'' will
supersede the November 1, 2000, guidance document and will serve as the
special control for these devices.
Following the effective date of any final reclassification rule
based on this proposal, 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
[[Page 8668]]
other way provides equivalent assurances of safety and effectiveness.
II. Significance of Guidance
This draft guidance document is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent 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 such approach
satisfies the requirements of the applicable statute and regulations.
III. Paperwork Reduction Act of 1995
This draft 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 draft 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). The labeling provisions addressed in the
guidance document have been approved by OMB under the PRA, OMB control
number 0910-0485.
IV. Comments
You may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments on the draft guidance. You
may submit a single copy of an electronic comment (see ADDRESSES).
Submit two copies of any mailed comments, but individuals may submit
one copy. You should identify your comment with the docket number found
in brackets in the heading of this document. You may see any comments
FDA receives in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
V. Electronic Access
To receive a copy of the draft guidance 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 draft guidance
document may also do so 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 notices, 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. Guidance documents are also available on the Division of
Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
Dated: February 11, 2004.
Beverly Chernaik Rothstein,
Acting Deputy Director for Policy and Regulations, Center for Devices
and Radiological Health.
[FR Doc. 04-3859 Filed 2-24-04; 8:45 am]
BILLING CODE 4160-01-S