Document ID: FDA-2008-D-0285-0005
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters; Availability
Posted Date: 2010-09-08T04:00Z

[Federal Register: September 8, 2010 (Volume 75, Number 173)]
[Notices]               
[Page 54637-54638]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08se10-82]                         

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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 
dsmica@fda.hhs.gov 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