80 FR 34678 - Content and Format of Abbreviated 510(k)s for Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 116 (June 17, 2015)

The Food and Drug Administration (FDA) is announcing the availability of the 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 guidance provides industry and Agency staff with recommendations for the suggested format and content of an abbreviated 510(k) submission for EGR1 gene FISH test system for specimen characterization devices.

[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34678-34679]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14881]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1242]


Content and Format of Abbreviated 510(k)s for Early Growth 
Response 1 Gene Fluorescence In-Situ Hybridization Test System for 
Specimen Characterization 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 ``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 guidance provides industry and Agency 
staff with recommendations for the suggested format and content of an 
abbreviated 510(k) submission for EGR1 gene FISH test system for 
specimen characterization devices.

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: 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 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 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 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 EGR1 gene FISH test system for 
specimen characterization devices and recommendations for addressing 
certain labeling issues relevant to the review process specific to 
these devices. An EGR1 gene 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 particular diagnosis, prognosis, and 
monitoring or risk assessment.
    In the Federal Register of September 26, 2014 (79 FR 57939), the 
Agency issued 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.'' The Agency received no comments on the 
draft guidance dated September 26, 2014.

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 
current thinking of FDA on ``Content and

[[Page 34679]]

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 establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This 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 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: June 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14881 Filed 6-16-15; 8:45 am]
 BILLING CODE 4164-01-P