[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Pages 57939-57940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22973]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1242]
Submissions for Early Growth Response 1 Gene Fluorescence In-Situ
Hybridization Test System for Specimen Characterization Devices; Draft
Guidance for Industry and Food and Drug Administration Staff;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availability of the draft guidance entitled ``Content and Format for
Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene
Fluorescence In-Situ Hybridization (FISH) Test System for Specimen
Characterization Devices.'' This draft guidance provides industry and
Agency staff with recommendations for the suggested format and content
of an abbreviated 510(k) submission for early growth response 1 (EGR1)
gene fluorescence in-situ hybridization (FISH) test system for specimen
characterization devices. This draft guidance is not final nor is it in
effect at this time.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 26, 2014.
ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Content and Format for Abbreviated 510(k)s for Early Growth Response
1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for
Specimen Characterization Devices'' to the Office of the Center
Director, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Shyam Kalavar, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5568, Silver Spring, MD 20993-0002, 301-796-6807.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance document was developed to provide industry and
Agency staff with recommendations for the suggested format and content
of an abbreviated 510(k) submission for early growth response 1 (EGR1)
gene fluorescence in-situ hybridization (FISH) test system for specimen
characterization devices and recommendations for addressing certain
labeling issues relevant to the review process specific to these
devices. An early growth response 1 (EGR1) gene fluorescence in-situ
hybridization (FISH) test system for specimen characterization is a
device intended to detect the EGR1 probe target on chromosome 5q in
bone marrow specimens from patients with acute myeloid leukemia or
myelodysplastic syndrome. The assay results are intended to be
interpreted only by a qualified pathologist or cytogeneticist. These
devices do not include automated systems that directly report results
without review and interpretation by a qualified pathologist or
cytogeneticist. These devices also do not include any device intended
for use to select patient therapy, predict patient response to therapy,
or to screen for disease as well as any device with a claim for a
[[Page 57940]]
particular diagnosis, prognosis, and monitoring or risk assessment.
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 content and
format for abbreviated 510(k)s for early growth response 1 (EGR1) gene
fluorescence in-situ hybridization (FISH) test system for specimen
characterization 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 downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Content and Format for
Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene
Fluorescence In-Situ Hybridization (FISH) Test System for Specimen
Characterization Devices'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 1400030 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently 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 21 CFR part 807, subpart E, are currently
approved under OMB control number 0910-0120 and the collections of
information in 21 CFR part 809.10 are currently approved under 0910-
0485.
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: September 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22973 Filed 9-25-14; 8:45 am]
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