[Federal Register Volume 74, Number 2 (Monday, January 5, 2009)]
[Notices]
[Pages 302-303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-31319]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0642]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Assay Migration Studies for In Vitro Diagnostic Devices; 
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availability of the draft guidance entitled ``Assay Migration Studies 
for In Vitro Diagnostic Devices.'' This draft guidance presents a least 
burdensome regulatory approach to gaining FDA approval of Class III or 
certain licensed in vitro diagnostic devices in cases when a previously 
approved assay is migrating (i.e., transitioning) to a New System for 
which the assay has not been previously approved or licensed.

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 6, 2009.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Assay Migration Studies for In Vitro 
Diagnostic Devices'' 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 or to the Office of Communication, Training, 
and Manufacturers Assistance (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 240-276-3151. 
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    Submit written comments concerning this draft guidance to the 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://www.regulations.gov. 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 (HFZ-440), 
Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 
240-276-0711.
    For further information concerning the guidance including 
statistical content as it relates to devices regulated by CBER: Stephen 
Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and 
Drug Administration, 1401 Rockville Pike, suite 200N Rockville, MD 
20852, 301-827-6210
    For further information concerning the statistical content in the 
guidance: Marina V. Kondratovich, Center for Devices and Radiological 
Health (HFZ-550), Food and Drug Administration, 1350 Piccard Drive, 
Rockville, MD 20850, 240-276-3126.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance presents a least burdensome regulatory approach 
to gain FDA's approval of Class III or certain licensed in vitro 
diagnostic devices, when a previously approved assay is migrating 
(i.e., transitioning) to a New System, for which the assay has not been 
previously approved or licensed. The regulatory approach in this 
guidance is also applicable to some 510(k) cleared devices, when the 
device transitioning to a new system presents specific concerns, either 
because of the nature of the analyte and indications, or because of the 
specific technology used (e.g., nucleic acid amplification tests). The 
focus of this guidance is on the study designs and performance criteria 
that should be fulfilled, so that sponsors can utilize the migration 
study approach in support of the change. The FDA believes that the 
assay migration study paradigm proposed in this draft guidance, 
provides a least burdensome scientific and regulatory pathway for 
manufacturers to transfer a previously approved or licensed assay, with 
full clinical data from an Old System to a New System (previously not 
approved or licensed). The paradigm is suitable in cases when 
sufficient knowledge can be derived from the documentation of design 
controls, risk analyses, and prior performance studies on an Old 
System.

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 assay 
migration studies for in vitro diagnostic devices. 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 ``Assay Migration Studies for In 
Vitro Diagnostic Devices,'' 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 240-276-3151 to receive a hard copy. Please use 
the document number 1660 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

[[Page 303]]

submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the CBER Internet site at http://www.fda.gov/cber/guidelines.htm or on the Division of Dockets Management Internet site 
at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations and guidance documents. 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 21 CFR part 
807 subpart E have been approved under OMB Control Number 0910-0120; 
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 801 and 809 have been approved under OMB Control Number 
0910-0485; the collections of information in 21 CFR 820 have been 
approved under OMB Control Number 0910-0073; and the collections of 
information in 21 CFR part 601 have been approved under OMB Control 
Number 0910-0338.

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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: December 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-31319 Filed 1-2-09; 8:45 am]
BILLING CODE 4160-01-S