[Federal Register: October 25, 2007 (Volume 72, Number 206)]
[Notices]
[Page 60682-60683]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25oc07-86]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0387]
Draft Guidance for Industry and Food and Drug Administration
Staff; In Vitro Diagnostic Device Studies--Frequently Asked Questions;
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availability of the draft guidance entitled ``Draft Guidance for
Industry and FDA Staff; In Vitro Diagnostic (IVD) Device Studies--
Frequently Asked Questions.'' This draft guidance document contains
information to assist manufacturers in developing and conducting
studies for IVD devices, particularly those exempt from most of the
Investigational Device Exemption (IDE) regulations. This draft guidance
is neither 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 before it begins work on the final version of the guidance,
submit written or electronic comments on the draft guidance by January
23, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Draft Guidance for Industry and FDA Staff;
In Vitro Diagnostic (IVD) Device Studies--Frequently Asked Questions''
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
[[Page 60683]]
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Submit written comments concerning this draft guidance to the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 either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments or 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
in
FOR FURTHER INFORMATION CONTACT:
Sally Hojvat, Center for Devices and Radiological Health (HFZ-312),
Food and Drug Administration,2098 Gaither Rd, Rockville, MD 20850, 301-
594-5940, ext. 114; or
Stephen M. Ripley, Center for Biologics Evaluation and Research
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite
200N, Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance is intended to facilitate the movement of new
IVD technology from the investigational stage to the marketing stage by
providing information about the development and conduct of IVD studies
that will be submitted to the agency to support premarket notifications
and applications. Because many IVD studies are exempt from most of the
IDE regulations at part 812 (21 CFR part 812) (Sec. 812.2(c)(3)), both
industry sponsors and FDA staff often have questions concerning the
relevant requirements and appropriate methods for such studies. This
draft guidance provides information about such studies as well as
general information about the development, conduct, and
responsibilities associated with all IVD studies. The Center for
Devices and Radiological Health (CDRH) and the Center for Biologics
Evaluation and Research (CBER) both have regulatory oversight of IVD
devices. Information in this draft guidance is relevant to IVD devices
regulated by either center under subchapter H of 21 CFR Chapter I.
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 IVD device
studies. 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 ``Draft Guidance for Industry and
FDA Staff; In Vitro Diagnostic (IVD) Device Studies--Frequently Asked
Questions'' 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
1587 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 on the CBER Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/.
guidelines.htm or 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 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
PRA). The collections of information in 21 CFR parts 50 and 56 have
been approved under OMB control number 0910-0130; the collections of
information in 21 CFR part 803 have been approved under OMB control
number 0910-0437; the collections of information in 21 CFR 807.87 have
been approved under OMB control number 0910-0120; the collections of
information in 21 CFR 809.10 have been approved under OMB control
number 0910-0485; the collections of information in 21 CFR part 810
have been approved under OMB control number 0910-0432; the collections
of information under part 812 have been approved under OMB control
number 0910-0078; the collections of information in part 814 (21 CFR
part 814), subparts B and E, have been approved under OMB control
number 0910-0231; the collections of information in part 814, subpart
H, have been approved under OMB control number 0910-0332; and the
collections of information in 21 CFR part 820 have been approved under
OMB control number 0910-0073.
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: October 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20982 Filed 10-24-07; 8:45 am]
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