[Federal Register Volume 70, Number 193 (Thursday, October 6, 2005)]
[Notices]
[Pages 58447-58448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-20092]


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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Draft Guidance for Industry and Food and Drug Administration 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 
Defibrillators; 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availability of the draft guidance entitled ``Functional Indications 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 This draft guidance is designed to describe ICD functional 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DATES: Submit written or electronic comments on this draft guidance by 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<gr-thn-eq> 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 
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    Submit written comments concerning this draft guidance to the 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.fda.gov/dockets/ecomments. Identify comments 
with the docket number found in brackets in the heading of this 
document.

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-
8517.
    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.

SUPPLEMENTARY INFORMATION:

I. Background

    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 
for a

[[Page 58448]]

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 (<greek-i>). 
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://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.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.

V. Comments

    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.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-20092 Filed 10-5-05; 8:45 am]
BILLING CODE 4160-01-S