[Federal Register Volume 78, Number 80 (Thursday, April 25, 2013)]
[Notices]
[Pages 24425-24426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09759]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Assay Migration Studies for In Vitro Diagnostic Devices; Guidance 
for Industry and Food and Drug Administration Staff; 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 ``Assay Migration Studies for In 
Vitro Diagnostic Devices.'' This guidance presents a least burdensome 
regulatory approach to gain 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, licensed, or cleared.

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 ``Assay Migration Studies for In Vitro Diagnostic 
Devices'' to the Division of Small Manufacturers, International and 
Consumer Assistance, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request, or fax your request to 
301-847-8149. Alternatively, you may submit written requests for single 
copies of the guidance to the Office of Communication, Outreach and 
Development (HFM-40), Center for Biologics Evaluation and Research 
(CBER), 1401 Rockville Pike, suite 200N, Rockville, MD 20852. 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 20993-002, 301-796-5455.
    For further information concerning the study designs in the 
guidance:

Marina V. Kondratovich, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
5666, Silver Spring, MD 20993-002, 301-796-6036.

    For further information concerning the guidance as it relates to 
devices regulated by CBER:

Stephen Ripley, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 
20852, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document for industry and FDA staff entitled 
``Assay Migration Studies for In Vitro Diagnostic Devices.'' This 
guidance presents a least burdensome regulatory approach to gain 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. The approach in this guidance is also 
applicable for some 510(k) cleared devices for which transition 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 
in order for a sponsor to utilize the migration study approach in 
support of the change. The FDA believes that the assay migration study 
paradigm discussed in this 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.
    The draft of this guidance was issued on January 5, 2009 (74 FR 
302). The comment period closed on April 6, 2009. Three sets of 
comments were received and reviewed by FDA. The guidance was updated to 
address comments where appropriate. The updated guidance contains 
additional examples and explanations and supersedes the draft guidance 
``Assay Migration Studies for In Vitro Diagnostic Devices'' issued on 
January 5, 2009.

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 ``migration studies'' for in vitro 
diagnostic device. 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 statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. 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. To receive 
``Assay Migration Studies for In Vitro Diagnostic Devices,'' you may 
either send an email 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 1660 to identify 
the guidance you are requesting. Guidance documents are also available 
on 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 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

[[Page 24426]]

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 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 either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: April 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09759 Filed 4-24-13; 8:45 am]
BILLING CODE 4160-01-P