[Federal Register: May 30, 2008 (Volume 73, Number 105)]
[Notices]
[Page 31127-31128]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my08-58]
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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Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance for industry and FDA staff entitled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 The draft
guidance was developed as the special controls to support the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 This draft guidance describes a means by which PTCA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 This draft guidance is not final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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Class II Special Controls Guidance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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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
dsmica@fda.hhs.gov 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://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 at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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