[Federal Register: October 6, 2005 (Volume 70, Number 193)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0391]
Draft Guidance for Industry and Food and Drug Administration
Staff; Functional Indications for Implantable Cardioverter
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Functional Indications
for Implantable Cardioverter Defibrillators.'' Many implantable
cardioverter defibrillators (ICDs) currently have a functional
indication. This draft guidance is designed to describe ICD functional
indications and the types of devices appropriate for the indication; to
provide guidance regarding labeling, advertising, and promotion of ICDs
with an approved functional indication and cardiac resynchronization
therapy defibrillators (CRT/ICDs) with an approved indication that
describes the function of the ICD component; and to discuss when to
submit an application for an investigational device exemption (IDE) for
a study involving a potential new patient population for an ICD with an
approved functional indication.
DATES: Submit written or electronic comments on this draft guidance by
January 4, 2006.
ADDRESSES: Submit written requests for single copies on a
3.5 diskette of the guidance document entitled ``Functional
Indications for Implantable Cardioverter Defibrillators'' 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 301-443-8818. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
Submit written comments concerning this draft guidance to the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.fda.gov/dockets/ecomments. Identify comments
with the docket number found in brackets in the heading of this
FOR FURTHER INFORMATION CONTACT:
For premarket issues: Owen Faris or Megan Moynahan, Center for
Devices and Radiological Health (HFZ-450), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
For promotion and advertising issues: Deborah Wolf, Center for
Devices and Radiological Health (HFZ-302), Food and Drug
Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4589.
Prior to June 2000, the indication statement for ICDs included
language to describe the types of patients who would benefit from an
ICD. If a manufacturer demonstrated in a clinical trial that a new
patient population benefited from its ICD, that manufacturer could
submit a premarket approval application (PMA) supplement to update its
indication statement to include that new patient population. That
manufacturer could then promote its ICD as indicated for the new
population. On June 20, 2000, FDA held a public meeting of the
Circulatory Systems Devices Panel to introduce the concept of a
functional indication. The functional indication describes what the
device does and does not explicitly specify as an indicated patient
population or expected outcome. FDA presented the functional indication
as a least burdensome method of allowing the clinical community to
identify the patient populations that would benefit from an ICD. The
panel endorsed the functional indication concept for ICDs and, since
that time, FDA has approved a functional indication for most
manufacturers' ICDs. This guidance document is intended to discuss the
intended patient population for ICDs with an approved functional
indication and CRT/ICDs with an approved indication that describes the
function of the ICD component, labeling, advertising, and promotion of
those ICDs and CRT/ICDs, and when to submit an application for an IDE
study involving a potential new patient population for an ICD with an
approved functional indication.
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 functional
indications for ICDs. 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
To receive ``Functional Indications for Implantable Cardioverter
Defibrillators `` by fax, 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 1304 followed by the pound sign ().
Follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the draft guidance may
also do so by 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 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 on the Division of
Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
IV. 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 (the PRA) (44 U.S.C. 3501-
3520). The collections of information addressed in the draft guidance
document have been approved by OMB in accordance with the PRA under the
regulations governing IDEs (21 CFR part 812, OMB control number 0910-
0078) and PMAs (21 CFR part 814, OMB control number 0910-0231). The
labeling provisions addressed in the guidance have been approved by OMB
under OMB control number 0910-0485.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this document
on or before January 4, 2006. Submit a single copy of electronic
comments or two paper copies of any mailed comments, except that
individuals may submit one 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.
Dated: September 29, 2005.
Assistant Commissioner for Policy.
[FR Doc. 05-20092 Filed 10-5-05; 8:45 am]
BILLING CODE 4160-01-S