Document ID: FDA-2009-D-0559-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications; Availability
Posted Date: 2010-01-20T05:00Z

[Federal Register: January 20, 2010 (Volume 75, Number 12)]
[Notices]               
[Page 3238]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ja10-76]                         

[[Page 3238]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0559]

 
Draft Guidance for Industry and Food and Drug Administration 
Staff; Heart Valves -- Investigational Device Exemption (IDE) and 
Premarket Approval (PMA) Applications; 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availability of the draft guidance document entitled ``Heart Valves -- 
Investigational Device Exemption (IDE) and Premarket Approval (PMA) 
Applications.'' This draft guidance document describes FDA's 
recommendations about investigational device exemption and premarket 
approval applications for heart valves. This draft guidance document is 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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 April 20, 2010.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Heart Valves -- Investigational Device 
Exemption (IDE) and Premarket Approval (PMA) Applications'' to the 
Division of Small Manufacturers, International, and Consumer 
Assistance, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Building 66, Room 4613, 
Silver Spring, MD 20993. 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    Submit written comments concerning this draft guidance to the 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: Carolyn D. Vaughan, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 1230, Silver Spring, MD 20993, 301-796-
6338.

SUPPLEMENTARY INFORMATION:

I. Background

    On October 14, 1994, FDA issued a guidance document on replacement 
heart valves (``the 1994 draft''), before the implementation of FDA's 
good guidance practices regulation. FDA withdrew the 1994 draft on 
January 5, 2005 (70 FR 824) and is now issuing this new draft guidance 
document for public comment. This draft guidance document describes 
FDA's recommendations about manufacturing, preclinical in vitro bench 
testing, preclinical in vivo studies, clinical investigations, and 
labeling that are different from or in addition to the recommendations 
of the International Organization For Standardization (ISO), ISO 
5840:2005, ``Cardiovascular Implants -- Cardiac Valve Prostheses'' (ISO 
5840). Although the draft guidance document provides complementary 
information to ISO 5840:2005, the draft guidance document can also be 
used with other methods equivalent to ISO 5840:2005.

II. Significance of Guidance

    This draft guidance document is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance 
document, when finalized, will represent the agency's current thinking 
on ``Heart Valves -- Investigational Device Exemption (IDE) and 
Premarket Approval (PMA) Applications.'' 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 ``Heart Valves -- Investigational 
Device Exemption (IDE) and Premarket Approval (PMA) Applications,'' 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 (1607).
    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. A search capability for all CDRH guidance documents is 
available at http://www.fda.gov/medicaldevices/
deviceregulationandguidance/guidancedocuments/default.htm. 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 draft guidance document contains information collection 
provisions that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 USC 3501-
3520) (the PRA). The collections of information in 21 CFR part 812 have 
been approved under OMB control number 0910-0078; the collections of 
information in 21 CFR part 814 have been approved under OMB control 
number 0910-0231; the collections of information in 21 CFR part 820 
have been approved under OMB control number 0910-0073; the collections 
of information in 21 CFR parts 801 and 809 have been approved under OMB 
control number 0910-0485; the collections of information in 21 CFR part 
58 have been approved under OMB control number 0910-0338; and the 
collections of information in parts 50 and 56 have been approved under 
OMB control number 0910-0130.

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.

    Dated: January 9, 2010.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. 2010-990 Filed 1-19-10; 8:45 am]
BILLING CODE 4160-01-S