[Federal Register Volume 79, Number 198 (Tuesday, October 14, 2014)]
[Notices]
[Pages 61644-61645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24308]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1351]


Flow Cytometric Devices; Draft Guidance for Industry and Food and 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availability of the draft guidance entitled ``Flow Cytometric 
Devices.'' This draft guidance addresses the current major review 
concerns regarding submissions for flow cytometric devices used as in 
vitro diagnostic devices for leukocyte immunophenotyping and provides 
suggestions on the content of submissions for these types of 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This draft guidance is not final nor is it in effect at this time.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 of 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 12, 2015.

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requests for a single hard copy of the draft guidance document entitled 
``Flow Cytometric 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, or Office of Communication, 
Outreach and Development, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
3128, 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Kevin Maher, Office of In Vitro 
Diagnostics and Radiological Health, Center for Devices and 
Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4246, Silver Spring, MD 20993-0002, 301-
796-6879, or Stephen Ripley, Center for Biologics Evaluation and 
Research (CBER), Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance addresses certain issues that arise in 
premarket submissions for flow cytometric devices used as in vitro 
diagnostic devices for leukocyte immunophenotyping and provides 
suggestions on the content of submissions for these types of devices. 
It is intended to be used in conjunction with the other cited guidance 
documents referenced therein. In preparing your submission to FDA, we 
recommend that you contact FDA's Office of In Vitro Diagnostics and 
Radiological Health (see FOR FURTHER INFORMATION CONTACT) for 
additional information regarding your submission. This draft guidance 
focuses on issues relevant to flow cytometric devices with an expanded 
scope of review topics that reflect the recognition of a flow 
cytometric device as an analytical system, which includes processing 
reagents, processing instrumentation, flow cytometers, and analytical 
software, in addition to the monoclonal antibody (mAb) component. The 
information presented in this draft guidance is based on the following: 
(1) Current basic science, (2) clinical experience, and (3) previous 
submissions by manufacturers to FDA. As advances are made in science 
and medicine, the content of this guidance will be re-evaluated and 
revised as necessary to accommodate new knowledge.
    This draft guidance is directed toward immunophenotyping of 
leukocytes using mAbs. However, the concepts may be applicable to 
related devices that utilize fluorochromes or fluorogenic substrates to 
measure ligand binding on solid particles in suspension, with or 
without mAbs. This draft guidance does not cover microscopy devices 
utilizing

[[Page 61645]]

fluorescent or chromogenic enzyme-substrate detection methods (e.g., 
immunohistochemical stains) nor does it cover the use of flow cytometry 
for cell enrichment and cell sorting/purification when used in cell 
therapy product manufacturing.

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 flow 
cytometric 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 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 or from CBER at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to download an electronic copy of ``Flow 
Cytometric Devices'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 1787 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously 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, have been 
approved under OMB control number 0910-0120, and the collections of 
information in 21 CFR part 801 and 21 CFR 809.10 have been approved 
under OMB control number 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: October 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24308 Filed 10-10-14; 8:45 am]
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