Document ID: FDA-2014-D-1242-0001
Agency: fda
Document Type: Notice
Title: 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Draft Guidance for Industry and Food and Drug Administration Staff;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
Posted Date: 2014-09-26T04:00Z

[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Pages 57939-57940]
From the Federal Register Online via the Government Printing 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Hybridization Test System for Specimen Characterization Devices; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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availability of the draft guidance entitled ``Content and Format for 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 This draft guidance provides industry and 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 This draft guidance is not final nor is it in 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 26, 2014.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requests for a single hard copy of the draft guidance document entitled 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 CDRH-Guidance@fda.hhs.gov 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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