[Federal Register Volume 69, Number 37 (Wednesday, February 25, 2004)]
[Notices]
[Pages 8667-8668]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3859]


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

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Draft Guidance for Industry and FDA Staff on Class II Special 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.

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

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availability of the draft guidance for industry and FDA staff entitled 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 The draft 
guidance is not final nor is it in effect at this time.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announcing the withdrawal of the 1994 draft guidance document entitled 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance on a 3.5'' diskette to the Division of Small Manufacturers, 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 Submit written comments on the draft guidance 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://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access to the draft guidance document.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://www.fda.gov/cdrh. A search capability for all CDRH 
guidance documents is available at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of 
Dockets Management Internet site at 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