[Federal Register: January 5, 2009 (Volume 74, Number 2)]
[Notices]
[Page 302-303]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ja09-65]
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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Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance entitled ``Assay Migration Studies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 This draft guidance presents a least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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Assay Migration Studies for In Vitro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Submit written comments concerning this draft guidance to the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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
dsmica@fda.hhs.gov 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
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submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the CBER Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm or on the Division of Dockets Management Internet site
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]
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