[Federal Register Volume 75, Number 122 (Friday, June 25, 2010)]
[Notices]
[Pages 36425-36426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15417]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0076] (formerly Docket No. 2007D-0387)


Guidance for Industry and Food and Drug Administration Staff; In 
Vitro Diagnostic 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 guidance entitled ``In Vitro Diagnostic (IVD) 
Device Studies--Frequently Asked Questions.'' FDA is issuing this 
guidance to assist manufacturers in developing and conducting studies 
for IVD devices, particularly those exempt from most of the 
Investigational Device Exemption (IDE) regulations. The guidance 
explains data considerations that ultimately will affect the quality of 
the premarket submission. The draft of this guidance was issued October 
25, 2007.

DATES:  Submit either electronic or written comments on this guidance 
at any time. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES:  Submit written requests for single copies of the guidance 
document entitled `` In Vitro Diagnostic (IVD) Device Studies--
Frequently Asked Questions'' to the Division of Small Manufacturers, 
International, and Consumer Assistance, Center for Devices and 
Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002, or to 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to CDRH at 301-847-8149. 
The guidance may also be obtained by mail by calling CBER at 1-800-835-
4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Sally Hojvat, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 5524, Silver Spring, MD 20993-0002, 301-796-5455; 
or
    Stephen 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 guidance facilitates 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)), industry 
sponsors and FDA staff often have questions concerning the relevant 
requirements and appropriate methods for such studies. This guidance 
provides information about such studies as well as general information 
about the development, conduct, and responsibilities associated with 
all IVD studies. CDRH and CBER both have regulatory oversight of IVD 
devices. Information in this guidance is relevant to IVD devices 
regulated by either center under chapter I of title 21 of the Code of 
Federal Regulations, subchapter H.
    In the Federal Register of October 25, 2007 (72 FR 60682), FDA 
announced the availability of the draft guidance. FDA received one 
comment regarding the use of investigational IVD devices in clinical 
drug trials. The comment addresses issues outside the scope of this 
guidance because this guidance makes recommendations for studies to 
support premarket notifications and approvals of IVD devices and does 
not address the use of investigational devices in clinical studies 
designed to evaluate new drug products.
    FDA made several minor wording changes to the guidance document in 
order to improve clarity, however there are no significant, substantive 
changes.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on ``In Vitro Diagnostic (IVD) Device 
Studies--Frequently Asked Questions.'' 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 guidance may do so by 
using the Internet. To receive ``In Vitro Diagnostic (IVD) Device 
Studies--Frequently Asked Questions,'' you may either send an e-mail 
request to [email protected] 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 1587 to identify the guidance you are 
requesting.
    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 at 
http://www.regulations.gov or the CBER Internet site at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm.

IV. Paperwork Reduction Act of 1995

    This 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 
collections of information in part 807 (21 CFR part 807), subpart E, 
including Sec.  807.87, have been approved under OMB control no. 0910-
0120; the collections of information in 21 CFR part 860 have been 
approved under OMB control no. 0910-0138; the collections of 
information in 21 CFR part 812 have been approved under OMB control no. 
0910-0078; the collections of information in 21 CFR parts 50 and 56 
have been approved under OMB control no. 0910-0130; the collections of 
information in 21 CFR part 803 have been approved under OMB control no. 
0910-0437; the collections of information in 21 CFR part 810 have been 
approved under OMB control no. 0910-0432; the collections of 
information in part 814 (21 CFR part 814), subparts B and E, have been 
approved under OMB control no. 0910-0231; the collections of 
information in part 814, subpart H, have been approved under OMB 
control no. 0910-0332; the collections of information in 21 CFR part 
820 have

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been approved under OMB control no. 0910-0073; the collections of 
information in 21 CFR part 610 have been approved under OMB control 
nos. 0910-0116 and 0910-0338; and the collections of information in 21 
CFR 809.10 have been approved under OMB control no. 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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: June 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-15417 Filed 6-24-10; 8:45 am]
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