Document ID: FDA-2013-D-0258-0007
Agency: fda
Document Type: Notice
Title: Combined Functionality for Molecular Diagnostic Instruments; Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2014-11-12T05:00Z

[Federal Register Volume 79, Number 218 (Wednesday, November 12, 2014)]
[Notices]
[Pages 67175-67176]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26694]

[[Page 67175]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0258]

Combined Functionality for Molecular Diagnostic Instruments; 
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 ``Molecular Diagnostic 
Instruments with Combined Functions.'' This guidance document provides 
industry and Agency staff with FDA's current thinking on regulation of 
molecular diagnostic instruments that combine in a single instrument 
both approved/cleared device functions and device functions for which 
approval/clearance is not required, and on the type of information that 
FDA recommends that applicants include in a submission for a molecular 
diagnostic instrument that measures or characterizes nucleic acid 
analytes and has combined functions.

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 
``Molecular Diagnostic Instruments With Combined Functions'' 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 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: Andrew Grove, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5515, Silver Spring, MD 20993-0002, 301-796-6198; 
or Stephen Ripley, Center for Biologics Evaluation and Research, 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 guidance document provides industry and Agency staff with 
FDA's current thinking on regulation of molecular diagnostic 
instruments that combine in a single instrument both approved/cleared 
device functions and device functions for which approval/clearance is 
not required, and on the type of information that FDA recommends that 
applicants include in a submission for a molecular diagnostic 
instrument that measures or characterizes nucleic acid analytes and has 
combined functions. Molecular diagnostic instruments, for example, 
real-time thermocyclers, are critical components of certain in vitro 
diagnostic devices. They are often used to perform multiple unrelated 
assays, such as those that detect methicillin resistant Staphylococcus 
aureus, hepatitis C virus, and genetic markers of cystic fibrosis. 
These types of instruments cannot generally be approved/cleared alone, 
i.e., without an accompanying assay, because their safety and 
effectiveness cannot be evaluated without reference to the assays that 
they run and their defined performance parameters. However, the same 
instruments may also be used for additional purposes that do not 
require FDA approval or clearance, such as for basic scientific 
research. In the past, FDA has provided informal advice in response to 
individual inquiries regarding the permissibility of having functions 
for which approval/clearance is not required on an instrument intended 
to be used with approved/cleared in vitro diagnostic assays. This 
guidance is meant to communicate FDA's policy regarding molecular 
diagnostic instruments with combined functions.
    This guidance applies to molecular diagnostic instruments that are 
medical devices used with assays that measure or characterize nucleic 
acid analytes, human or microbial, and that combine both approved/
cleared and non-approved/non-cleared functions in a single instrument. 
This guidance applies to the instrument itself (hardware) as well as to 
any firmware or software intended to operate on or to control the 
instrument. This guidance also addresses software that is distributed 
as a stand alone device for use with an approved/cleared molecular 
diagnostic assay.
    The guidance does not apply to instruments approved/cleared for use 
with assays that are intended to screen donors of blood and blood 
components, human cells, tissues, and cellular and tissue-based 
products, for communicable diseases. The document also does not apply 
to instruments approved/cleared for blood grouping. We encourage 
manufacturers wishing to market such instruments with combined 
functionality to contact the appropriate office in the Center for 
Biologics Evaluation and Research (CBER).
    The recommendations in this guidance do not apply to assays and 
reagents. They are also not intended to change FDA's position regarding 
the marketing of Research Use Only and Investigational Use Only assays 
for clinical use.
    The draft guidance was announced in the Federal Register of April 
9, 2013 (78 FR 21128), and the comment period closed on July 8, 2013. 
Several comments were received during the comment period. We took the 
suggestions into consideration in revising and finalizing this 
guidance.

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 
Agency's current thinking on molecular diagnostic instruments with 
combined functions. 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 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 or from

[[Page 67176]]

CBER at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to 
download an electronic copy of ``Molecular Diagnostic Instruments With 
Combined Functions'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 1763 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This 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; the collections of 
information in 21 CFR part 803 have been approved under OMB control 
number 0910-0437; 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: November 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26694 Filed 11-10-14; 8:45 am]
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