[Federal Register Volume 75, Number 173 (Wednesday, September 8, 2010)]
[Notices]
[Pages 54637-54638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22303]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0285]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document for Certain Percutaneous
Transluminal Coronary Angioplasty (PTCA) Catheters; 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 guidance entitled ``Class II Special Controls
Guidance Document for Certain Percutaneous Transluminal Coronary
Angioplasty (PTCA) Catheters.'' The guidance was developed as a special
control to support the reclassification of PTCA catheters, other than
cutting/scoring PTCA catheters, from class III (premarket approval)
into class II (special controls). This guidance describes a means by
which PTCA catheters, other than cutting/scoring PTCA catheters, may
comply with the requirement of special controls for class II devices.
Elsewhere in this issue of the Federal Register, FDA is publishing a
final rule that codifies the reclassification of this device type from
class III (premarket approval) into class II (special controls).
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Class II Special Controls Guidance Document for
Certain Percutaneous Transluminal Coronary Angioplasty (PTCA)
Catheters'' to the Division of Small Manufacturers, International, and
Consumer Assistance (HFZ-220), Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request, or fax
your request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Kathryn O'Callaghan, Center for
Devices and Radiological Health (HFZ-450), Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-6349.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance document was developed as a special control guidance
to support the reclassification of PTCA catheters, other than cutting/
scoring PTCA catheters, into class II (special controls). The device is
intended for balloon dilatation of a hemodynamically significant
coronary artery or bypass graft stenosis in patients evidencing
coronary ischemia for the purpose of improving myocardial perfusion,
treatment of acute myocardial infarction, treatment of in-stent
restenosis and/or post-deployment stent expansion. Cutting/scoring PTCA
catheters (Product Code: NWX) remain in class III and are subject to
premarket
[[Page 54638]]
approval (PMA) requirements (section 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360e)).
On December 4, 2000, at a public meeting of FDA's Circulatory
System Devices Panel (the Panel), the Panel recommended that PTCA
catheters, other than cutting/scoring PTCA catheters and standard PTCA
catheters for the treatment of in-stent restenosis and/or post-
deployment stent expansion, be reclassified from class III to class II,
when indicated for balloon dilatation of a hemodynamically significant
coronary artery or bypass graft stenosis in patients evidencing
coronary ischemia for the purpose of improving myocardial perfusion, or
for treatment of acute myocardial infarction. The Panel recommended a
guidance document, labeling, and postmarket surveillance as special
controls.
FDA considered the Panel's recommendations and, on May 30, 2008,
published a proposed rule to reclassify certain PTCA catheters,
including standard PTCA catheters for the treatment of in-stent
restenosis and/or post-deployment stent expansion, but not cutting/
scoring PTCA catheters, into class II. In addition, FDA issued a draft
class II special controls guidance document entitled ``Class II Special
Controls Guidance Document for Certain Percutaneous Transluminal
Coronary Angioplasty (PTCA) Catheters'' to support the proposed
reclassification.
Following publication of the draft guidance, two sets of comments
on the guidance were submitted to the FDA. The comments received sought
minor clarifications on several pre-clinical testing recommendations,
including biocompatibility, shelf-life and performance testing. We
considered the suggestions and made appropriate revisions. In addition,
the guidance was updated to include more specific recommendations
regarding evaluation of coating integrity. FDA is now identifying the
guidance document entitled ``Class II Special Controls Guidance
Document for Certain Percutaneous Transluminal Coronary Angioplasty
(PTCA) Catheters'' as the guidance document that will serve as the
special control for this device type.
The guidance document provides a means by which PTCA catheters,
other than cutting/scoring PTCA catheters, may comply with the
requirement of special controls for this class II device. Following the
effective date of the final reclassification rule, any firm submitting
a premarket notification (510(k)) for a PTCA catheter 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.
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 standard PTCA catheters. 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. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``Class II Special Controls Guidance
Document for Certain Percutaneous Transluminal Coronary Angioplasty
(PTCA) Catheters'' you may either send an e-mail request to
[email protected] to receive an electronic copy of the document or
send a fax request to 301-847-8149 to receive a hard copy. Please use
the document number (1608) to identify the guidance you are requesting.
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. Guidance documents are also
available on the Division of Dockets Management Internet site at http://www.regulations.gov.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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
collections of information in 21 CFR part 807, Subpart E, have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 812 have been approved under OMB control
number 0910-0078; the collections of information under CFR parts 50 and
56 have been approved under OMB control number 0910-0130; the
collections of information in 21 CFR part 820 have been approved under
0910-0073; and the collections of information in 21 CFR part 801 have
been approved under OMB control number 0910-0485.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: August 31, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-22303 Filed 9-7-10; 8:45 am]
BILLING CODE 4160-01-S