[Federal Register Volume 78, Number 68 (Tuesday, April 9, 2013)]
[Notices]
[Pages 21128-21129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08167]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Molecular Diagnostic Instruments With Combined Functions; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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availability of the draft guidance entitled ``Molecular Diagnostic 
Instruments with Combined Functions.'' This draft guidance document 
provides industry and Agency staff with FDA's current thinking on 
regulation of molecular diagnostic instruments that have both device 
functions and non-device functions, 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. This draft guidance is not final 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 8, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Molecular Diagnostic Instruments with 
Combined Functions'' to the Division of Small Manufacturers, 
International, and Consumer Assistance, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-847-8149. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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:  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 Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research, RKWL Bldg., suite 601, 11400 
Rockville Pike, Rockville, MD 20852, 1-800-835-4709.

SUPPLEMENTARY INFORMATION: 

I. Background

    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 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 such non-device functions on an instrument 
intended to be used with approved in vitro diagnostic assays. This 
draft guidance is meant to communicate FDA's policy regarding molecular 
diagnostic instruments with combined functions.
    This draft 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 and non-approved functions in a single instrument. This draft 
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 draft guidance also addresses software that is 
distributed as a stand alone device for use with an approved molecular 
diagnostic assay.
    The draft guidance does not apply to instruments approved 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 recommendations in this draft guidance are not intended to 
imply that assays/reagents that have not received FDA marketing 
authorization may be marketed by an instrument manufacturer for 
clinical use on a molecular diagnostic instrument with combined 
approved and non-approved functions. 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.

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 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 draft guidance may do 
so by using 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. To receive ``Molecular Diagnostic 
Instruments with Combined Functions,'' you may either send an email 
request to [email protected] to receive an electronic copy of the 
document or send a fax request to 301-847-8149 to receive a hard copy. 
Please use the document number 1763 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 and guidance documents. 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

[[Page 21129]]

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: April 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08167 Filed 4-8-13; 8:45 am]
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