[Federal Register Volume 73, Number 105 (Friday, May 30, 2008)]
[Notices]
[Pages 31127-31128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12116]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0285]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Class II Special Controls Guidance Document for Certain 
Percutaneous Transluminal Coronary Angioplasty 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availability of the draft guidance for industry and FDA staff entitled 
``Class II Special Controls Guidance Document for Certain Percutaneous 
Transluminal Coronary Angioplasty (PTCA) Catheters.'' The draft 
guidance was developed as the special controls to support the 
reclassification of PTCA catheters, other than cutting/scoring PTCA 
catheters, from class III (premarket approval) into class II (special 
controls). This draft guidance describes a means by which PTCA 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 issuing for public comment 
the recommendation of the Circulatory System Devices Panel (the Panel) 
to reclassify PTCA catheters, other than cutting/scoring PTCA 
catheters, from class III to class II. This draft guidance is not final 
nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by August 28, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Class II Special Controls Guidance 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, 1350 Piccard 
Dr., Rockville, MD 20850. Send one self-addressed adhesive label to 
assist that office in processing your request, or fax your request to 
240-276-3151. See the SUPPLEMENTARY INFORMATION section for information 
on electronic access to the guidance.
    Submit written comments concerning this 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.regulations.gov. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Kathryn O'Callaghan or Suzanne Kaiser, 
Center for Devices and Radiological Health (HFZ-450), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4222

SUPPLEMENTARY INFORMATION:

I. Background

    The draft 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.
    On September 21, 2000, FDA filed a petition submitted under section 
513(f)(3) of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 360c(f)(3)) from Cook Group Inc. (COOK) requesting 
reclassification of PTCA catheters from class III into class II. (This 
reclassification petition did not include cutting or scoring PTCA 
catheters.) In accordance with section 513(f)(1) of the act, the PTCA 
catheter was automatically classified into class III because the PTCA 
catheter was not within a type of device which was introduced or 
delivered for introduction into interstate commerce for commercial 
distribution before May 28, 1976, and had not been found substantially 
equivalent to a device placed in commercial distribution after May 28, 
1976, which was subsequently reclassified into class II or class I.
    At a public meeting on December 4, 2000, the Panel recommended 
(seven to one) that PTCA catheters, other than cutting/scoring PTCA 
catheters, 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

[[Page 31128]]

perfusion; or for treatment of acute myocardial infarction. The Panel 
believed that class II with special controls, such as this draft 
guidance document, would reasonably ensure the safety and effectiveness 
of the device.
    The Panel recommended that PTCA catheters for the treatment of in-
stent restenosis and/or post-deployment stent expansion not be included 
because of a lack of sufficient information about this use. Since the 
Panel meeting, however, additional data regarding this use have become 
available and have been reviewed by the agency. Following the public 
meeting, FDA reviewed adverse event reports submitted to FDA's 
Manufacturer and User Facility Device Experience Database (MAUDE). The 
agency believes that the types of risks associated with the use of PTCA 
catheters for the treatment of in-stent restenosis and/or post-
deployment stent expansion are similar enough to the risks associated 
with treatment of de novo lesions, such that the special controls 
discussed at the Panel meeting, with the addition of recommendations 
for specific nonclinical performance testing and the recommendation 
that in-stent restenosis patients be included in the clinical 
evaluation, when necessary, are adequate to control the risks to health 
for these devices.

II. Significance of Guidance

    This draft guidance 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 this topic. 
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 draft 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 240-276-3151 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 at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft 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; 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), 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. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: May 21, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-12116 Filed 5-29-08; 8:45 am]
BILLING CODE 4160-01-S