[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]
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