[Federal Register: June 25, 2010 (Volume 75, Number 122)] [Notices] [Page 36425-36426] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr25jn10-70]
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.
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
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;
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.
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
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 firstname.lastname@example.org 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
A search capability for all CDRH guidance documents is available at
GuidanceDocuments/default.htm. Guidance documents are also available at
http://www.regulations.gov or the CBER Internet site at http://
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
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.
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.
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-15417 Filed 6-24-10; 8:45 am] BILLING CODE 4160-01-S