[Federal Register: January 20, 2024 (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Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance document entitled ``Heart Valves --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 This draft guidance document describes FDA's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 This draft guidance document is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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Heart Valves -- Investigational Device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Submit written comments concerning this draft guidance to the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, 2024 (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
SOURCE